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80 Clinical Trials near New Jersey
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Hyperpolarized Gas MRI for Bronchopulmonary Dysplasia
Philadelphia, PennsylvaniaHyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder. As a nonionizing technique, MRI is an ideal modality for pulmonary imaging; in particular in the infant and pediatric population. Nevertheless, due to the low proton density of the lung parenchyma (only \~20% that of solid tissues), numerous air-tissue interfaces that lead to rapid signal decay, and cardiac and respiratory sources of motion that further degrade image quality , MRI has played a limited role in the evaluation of lung pathologies. In this setting, HP gas (using 129Xe) MRI may play a role in helping determine the regional distribution of alveolar sizes, partial pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the microvasculature within the lungs of infants with a diagnosis of bronchopulmonary dysplasia (BPD).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:< 1
Sex:All
30 Participants Needed
HIV Vaccine for HIV Prevention
New York, New YorkThis is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time this combination of study products is being tested in people.
The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease).
Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health.
Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 55
Sex:All
25 Participants Needed
DV700P-RNA + DV701B1.1-RNA for HIV
New York, New YorkThis is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people.
The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease).
Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 55
Sex:All
45 Participants Needed
CAY001 for Healthy Volunteers
Fair Lawn, New JerseyThis is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001 when administered to healthy male and female subjects. Up to 6 dose levels will be evaluated with a total of approximately 48 subjects.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 50
Sex:All
48 Participants Needed
Hezkue for Erectile Dysfunction
New York, New YorkThe objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:20 - 70
Sex:Male
12 Participants Needed
Army-SPRING for Suicide Prevention
Philadelphia, PennsylvaniaEvery unit in the Connecticut Army National Guard has a Suicide Intervention Officer to provide suicide intervention education awareness for their unit, monitor for soldiers in crisis and connect soldiers with helping resources and agencies. Suicide Intervention Officers need support in this difficult role, yet there is limited guidance on how to help them. This study will shed light on how to support Suicide Intervention Officers and whether this support results in reduced suicide risk in their units.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:All
Sex:All
57 Participants Needed
ARN-75039 for Lassa Fever
Secaucus, New JerseyARN-75039-103 is a comparative, randomized, single-dose, crossover study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules against ARN 75039 with excipients in tablet form administered by the oral route in healthy adult participants. The safety assessments will include standard evaluations of vital signs, clinical laboratory values, and ECGs.
Participants will be admitted to the study site on the morning of Day -1, prior to Period 1 study drug administration, and will remain on site until Day 15. Upon confirmation of eligibility, participants will be randomized into the study on Day 1. Study drug administration will be performed on the first day of Periods 1 and 2 (Study Days 1 and 8, respectively) with a 7-day washout period between the two periods. Participants will receive the randomized study drug in the morning following a meal. A total of 16 participants will be randomized 1:1 to the following two sequences:
* Sequence 1:
* Period 1: Neat ARN-75039 in HPMC capsules (reference product)
* Period 2: ARN-75039 with excipients in tablet form (comparator)
* Sequence 2:
* Period 1: ARN-75039 with excipients in tablet form (comparator)
* Period 2: Neat ARN-75039 in HPMC capsules (reference product)
Participation in the study will be conducted in the following 5 defined periods:
* Screening Period: The Screening Period begins upon completion of the informed consent form (ICF). During this period, participants will undergo baseline assessments to determine eligibility for study participation. The Screening Period duration will be up to 21 days; it will end after all evaluations required to meet eligibility have been completed. If a participant meets all eligibility criteria, they will be offered enrollment into the study.
* Admission to Study Site: Participants will be admitted to the study site in the morning on the day prior to dosing of period 1 (Day -1). Participants that are eligible to participate in the study and are randomized into the study will remain at the study site until completion of the treatment period (Study Day 15).
* Treatment Period: This study consists of two treatment days separated by a 7-day washout period. The first treatment day will begin on Day 1 of Period 1 with administration of the first dose of study drug. The second treatment day will occur on the first day of Period 2 (Study Day 8). Following the dosing of the study drug on each treatment day, fifteen venous blood samples will be withdrawn via an indwelling cannula or by venipuncture at regular time intervals.
* End of Active Treatment (Day 15 Discharge Visit or Early Termination (ET) Visit): Upon successful completion of active treatment, participants will be discharged from the study site on Study Day 15. The Discharge Visit will include the completion of safety assessments, such as a physical examination, vitals, ECG recording, adverse event review, and clinical laboratory tests. Participants who complete both dosing days will be encouraged to complete all study visits.
Participants who do not complete all study visits or terminate from the study prior to Day 15 will be asked to complete the Early Termination Visit within 1 day after withdrawal from the study.
• Day 36 Telephone Follow Up Phone Call: Participants will be contacted by phone on Day 36-i.e., 28 days following the last study dose administered on Day 8. The purpose of this follow-up call is to assess for any adverse events.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:All
16 Participants Needed
Vaccine Regimen for HIV Prevention
New York, New YorkThis is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum.
The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum.
426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Sex:All
42 Participants Needed
Palovarotene for Liver Disease
Philadelphia, PennsylvaniaThe main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function.
The study will also assess the safety and tolerability of the single dose of palovarotene.
Participants will be enrolled in stages and divided into three groups based on their liver function:
* Group 1: Healthy participants with normal liver function
* Group 2: Participants with moderate liver impairment
* Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable)
Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
32 Participants Needed
RG1-VLP Vaccine for HPV-Related Cancers
Staten Island, New YorkThis phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus (HPV)-related cancers in women. RG1-VLP is a vaccine that aims to protect against rare HPV types not targeted by currently approved HPV vaccines. HPV is a common sexually-transmitted infection that can cause certain genital and oral cancers. RG1-VLP contains a protein of HPV type 16 (HPV16) with a slightly different structure than the licensed Gardasil-9 vaccine. Gardasil-9 is approved by the Federal Drug Administration to help protect against diseases caused by some types of HPV. Gardasil-9 also contains 9 different HPV proteins. Both vaccines contain alum to stimulate the immune system. The usual approach for the prevention of HPV-related cancers for patients who are at increased risk is to consider the currently approved HPV vaccine like Gardasil-9, as well as to be followed closely by their doctor to watch for the development of cancer via routine pap smears. This trial may allow researchers to find out whether the RG1-VLP vaccine can safely trigger an immune response against HPV in healthy women and if it is better or worse than the usual approach for the prevention of HPV-related cancers.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Genital Warts, Cancer Treatment, Auto-immune, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
33 Participants Needed
Varegacestat for Healthy Volunteers
Secaucus, New JerseyThis clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 55
Sex:Male
Key Eligibility Criteria
Disqualifiers:Recent Investigational Drug, Radiation, Others
6 Participants Needed
Flu and COVID-19 Vaccines for Coronavirus and Influenza
Philadelphia, PennsylvaniaThe purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.
This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
2050 Participants Needed
Heart Health Supplement for High Cholesterol
New York, New YorkWe are running a 3-month trial of an experimental natural heart health supplement. Participants will take a daily dose of an experimental natural heart health supplement in powdered format, chocolate flavor. The trial will assess changes in heart biomarkers such as Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:21+
Sex:All
60 Participants Needed
Nanosensor for Mitochondrial Myopathy
Philadelphia, PennsylvaniaPast mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Cardiac Disease, Severe Pulmonary Disease, Bleeding Disorders, Others
Must Not Be Taking:Aspirin, Immunosuppressants, Corticosteroids
96 Participants Needed
Lithium + Valproic Acid + KarXT for Healthy Subjects
Princeton, New JerseyThe purpose of this study is to evaluate the effects of lithium and valproic acid on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium and valproic acid in healthy participants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Hepatic, Renal, Pancreatitis, Others
88 Participants Needed
mRNA Vaccines for HIV Prevention
Philadelphia, PennsylvaniaThis is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are:
1. the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors,
2. the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and
3. these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Immunodeficiency, Others
Must Not Be Taking:Glucocorticoids, Immunoglobulin, Antiseizure, Others
48 Participants Needed
Combination Vaccine for COVID-19 and Flu
New York, New YorkStudy VBT00001 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States.
The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1) (coadministered in opposite arms).
Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, and IIV-HD + rC19 study groups to control for the number of injections and to maintain observer-blinding.
Thus, each participant will receive two injections at enrollment, one in each deltoid muscle.
Study details include:
* The study duration will be approximately 12 months
* Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on D01
* Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose)
* The visit frequency will be D01, D09 (telephone call), D30, D182 (telephone call), and D366 (telephone call)
Number of Participants:
Approximately 980 participants are expected to be randomized.
Stay on current meds
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:50+
Sex:All
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Bleeding Disorder, Stroke, Others
Must Not Be Taking:Immunosuppressants, Anticoagulants
980 Participants Needed
UTI Vaccine for Urinary Tract Infections
Secaucus, New JerseyThe purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 64
Sex:All
Key Eligibility Criteria
Disqualifiers:Immunodeficient, Neurological Disorders, Others
Must Not Be Taking:Antibiotics, Methenamine, D-mannose
448 Participants Needed
IVT GBS-06 Vaccine for Asymptomatic Carriers
New York, New YorkTo assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 49
Sex:Female
Key Eligibility Criteria
Disqualifiers:Neurological Disease, Depression, Immunodeficiency, Others
Must Not Be Taking:Immunomodulators, Corticosteroids, Others
600 Participants Needed
Ketorolac + Lidocaine for Pain Relief During Hysteroscopy
New York, New YorkA randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Thrombocytopenia, Gastritis, Renal Disease, Others
Must Not Be Taking:Narcotics, NSAIDs
44 Participants Needed
LY4006895 for Alzheimer's Disease
Marlton, New JerseyThe main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD).
Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it.
This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:45 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Serious Illnesses, Suicidal, Drug Abuse, Others
Must Not Be Taking:Anti-tau, Amyloid Therapies
68 Participants Needed
Insulin Regulation for Insulin Resistance
New York, New YorkThe goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement of insulin at two different levels (low and high), with or without replacement of glucagon, and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Diseases, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Antipsychotics, Antidepressants, Others
15 Participants Needed
E-CEL UVEC Cells for Anal Fissures
New York, New YorkThis clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Diseases, Active Infection, Others
Must Not Be Taking:Systemic Chemotherapy, Local Pelvic Radiation
12 Participants Needed
Fecal Transplant for Antibiotic-Related Gut Disruption
New Brunswick, New JerseyAntibiotics are lifesaving therapeutic drugs which have been used by adults, children, and infants alike for decades. There is an increase in global use of antibiotics over the course of lifetime and earlier in lifetime, with some countries recording as high as 12 courses a year in children younger than two. While antibiotics are successful in eradicating many pathogenic bacteria, research has demonstrated significant effect on beneficial gut microbiota, including long-lasting shift in the dynamics, composition, richness, and maturity of the intestinal flora. Microbiota alterations during early life, including through antibiotics use as well as birth via C-section, constitute a developmental perturbation, which increases the risk of modern diseases of immune and metabolic dysfunction. Strong epidemiological evidence suggests associations between early stressors of the microbiota and a number of common diseases, such as obesity, asthma, allergies, celiac disease, and Type 1 Diabetes. Furthermore, excess antibiotic exposure is associated with the development of neurological and psychiatric disorders. Currently, no strategies exist to restore the microbiome other than reliance on spontaneous repair mechanism, which often takes months in a healthy individual barring further antibiotic exposure. Contrary to popular belief, ingestion of probiotics, particularly after antibiotics, has been demonstrated to slow down the repair as it introduces an exogenous and massive amounts of only a few types of bacterial strains into a finely-tuned ecosystem of hundreds of different strains.
It is hypothesized that by preserving the child's microbiome prior to antibiotic therapy and reintroducing it afterwards through an autologous fecal matter transplant (FMT) will assist in a quick, effective, and host-specific microbiome recolonization to the levels and patterns to those prior to antibiotics. This would in turn reduce the overall loss of microbiome diversity over the child's lifespan, essentially providing a 'reset' option to the child's most unadulterated version of microbiome. This approach utilizes delivering the sample by mixing it in maternal milk or formula and feeding it to the child through a bottle, which can be performed anywhere without any discomfort for the child.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:1 - 4
Sex:All
Key Eligibility Criteria
Disqualifiers:Recent Antibiotics, Immunological Condition
40 Participants Needed
BMS-986470 for Sickle Cell Disease
Philadelphia, PennsylvaniaThe purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe VOCs, Acute Chest Syndrome, Others
Must Be Taking:Hydroxyurea
184 Participants Needed
Exosomes + Microneedling for Male Pattern Baldness
Brooklyn, New YorkThe purpose of this study is to determine whether Wharton's Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia (pattern hair loss).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
100 Participants Needed
IMNN-101 Vaccine for COVID-19
Philadelphia, PennsylvaniaThis is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
74 Participants Needed
Modified RNA Vaccines for Flu
Philadelphia, PennsylvaniaThe purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:
* safe; and
* how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.
RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.
Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.
The study is seeking for participants who:
* are at least 18 years of age
* have not received an influenza vaccine within the last 6 months
* are generally healthy
This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).
All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:
* 1 of the modRNA influenza vaccines that is being studied; or
* an approved influenza vaccine approved for use in their respective age group.
Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
1202 Participants Needed
Alpelisib for Insulin Resistance
New York, New YorkThe goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Liver, Psychiatric, Others
Must Not Be Taking:Antidiabetics, Lipid-lowering, Antipsychotics, Corticosteroids
32 Participants Needed
SR604 for Hemophilia
Philadelphia, PennsylvaniaThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors (Part B).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 60
Sex:Male
Key Eligibility Criteria
Disqualifiers:Thrombosis, Cardiac Disease, Hypertension, HIV, Others
36 Participants Needed
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Frequently Asked Questions
How much do clinical trials in New Jersey pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in New Jersey work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in New Jersey 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in New Jersey is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in New Jersey several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in New Jersey ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in New Jersey ?
Most recently, we added Hyperpolarized Gas MRI for Bronchopulmonary Dysplasia, HIV Vaccine for HIV Prevention and DV700P-RNA + DV701B1.1-RNA for HIV to the Power online platform.