AFA-281 Safety Study in Healthy Volunteers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Afasci Inc
Trial Summary
What is the purpose of this trial?This trial tests a new drug, AFA-281, in healthy volunteers to check its safety and how it behaves in the body. Volunteers take the drug for a short period. Researchers measure drug levels in the blood and monitor for any side effects.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for healthy volunteers with no significant medical history, it's likely that participants should not be on any regular medications.
What data supports the idea that AFA-281 Safety Study in Healthy Volunteers is an effective treatment?
The available research does not provide any specific data or evidence supporting the effectiveness of AFA-281 Safety Study in Healthy Volunteers as a treatment. The articles focus on other topics such as patient outcomes after femoral neck fracture, patient willingness to question healthcare staff, adverse events in hospitalized patients, and quality improvement in radiation oncology. None of these studies directly address the effectiveness of AFA-281.
12345What existing safety data is available for AFA-281?
The provided research does not specifically mention AFA-281 or its safety data. However, it discusses general safety data from phase I studies involving healthy volunteers, including adverse events and safety assessments in early drug development. These studies highlight the importance of monitoring adverse events and using microdose studies to improve safety assessments in early drug trials.
678910Eligibility Criteria
This trial is for healthy volunteers with a BMI between 18.0 and 30.0, no significant medical history, normal lab values, and a normal ECG. People with any significant health issues or abnormal test results cannot participate.Inclusion Criteria
Your heart test (ECG) should not show any important problems.
Your body mass index (BMI) must be between 18.0 and 30.0 kg/m2.
I am in good health with no major medical issues.
+1 more
Exclusion Criteria
You have significant abnormal medical conditions.
You have abnormal results on an ECG test.
Participants with significant medical history or clinically significant abnormalities
Participant Groups
The study tests AFA-281 in two parts: Part 1 gives single doses to groups of volunteers to check safety and how the body processes the drug. If safe, Part 2 has them take it for 14 days to further assess these factors.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AFA-281Experimental Treatment1 Intervention
Part 1: AFA-281 administered as an oral capsule at 5 dose levels for one day.
Part 2: AFA-281 administered as an oral capsule at 3 dose levels twice daily for 14 consecutive days. Doses will be determined after completion of Part 1.
Group II: Placebo ControlPlacebo Group1 Intervention
Double blind placebo control
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CenExcel CNSLos Alamitos, CA
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Who Is Running the Clinical Trial?
Afasci IncLead Sponsor
Cognitive Research CorporationIndustry Sponsor
References
Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. [2018]Prospective studies on patient related outcome in patients
How willing are patients to question healthcare staff on issues related to the quality and safety of their healthcare? An exploratory study. [2022]One in 10 patients admitted to hospital will suffer an adverse event as a result of their medical treatment. A reduction in adverse events could happen if patients could be engaged successfully in monitoring their care.
[Identification of adverse events in hospitalised influenza patients]. [2017]To test the inter-observer agreement in identifying adverse events (AE) in patients hospitalized by flu and undergoing precautionary isolation measures.
Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. [2023]One way to decrease adverse events is to increase patient participation in their own care. Sahlgrenska University Hospital has introduced a patient safety advisory, consisting of an animated video and structured oral information. This article investigates how the animated video and structured oral information regarding was perceived by the patients and determines which communication method the patients preferred.
Quality improvement program in radiation oncology: understanding patient hospitalizations, treatment breaks, and weight loss in patients receiving radiotherapy. [2019]The reporting of adverse effects is an integral aspect of a hospital quality improvement (QI) program with the goal of improving care for current and future patients. We report the results of our experience tracking patient hospitalizations, treatment breaks, and weight loss in patients receiving radiotherapy as part of a departmental QI program.
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]This report describes all clinical, laboratory and electrocardiographical adverse events detected in healthy volunteers in a phase-I centre over a 10-year period: 54 phase-I studies are involved, including 1015 healthy young volunteers (993 males) who received 1538 treatments (23 different active drugs or placebo) corresponding to 12143 days of follow-up. This updates a similar report published previously in the European Journal of Clinical Pharmacology.
Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. [2019]Testing the safety and efficacy of a successful human medicine involves many laboratory animals, which can sometimes be subjected to considerable suffering and distress. Also, it is necessary to extrapolate from the test species to humans. UK and European legislation requires that Replacement, Reduction and Refinement of animal procedures (the Three Rs) are implemented wherever possible. Over the last decade, there has been substantial progress with applying in vitro and in silico methods to both drug efficacy and safety testing. This paper is a report of the discussions and recommendations arising from a workshop on the role that might be played by human volunteer studies in the very early stages of drug development. The workshop was organised in November, 2001 by Volunteers in Research and Testing, a group of individuals in the UK which launched an initiative in 1994 to identify where and how human volunteers can participate safely in biomedical studies to replace laboratory animals. It was considered that conducting pre-Phase I very low dose human studies (sub-toxic and below the dose threshold for measurable pharmacological or clinical activity) could enable drug candidates to be assessed earlier for in vivo human pharmacokinetics and metabolism. Moreover, accelerator mass spectrometry (AMS), nuclear magnetic resonance (NMR) spectroscopy and positron emission tomography (PET) are potentially useful spectrometric and imaging methods that can be used in conjunction with such human studies. Some, limited animal tests would still be required before pre-Phase I microdose studies, to take account of the potential risk posed by completely novel chemicals. The workshop recommended that very early volunteer studies using microdoses should be introduced into the drug development process in a way that does not compromise volunteer safety or the scientific quality of the resulting safety data. This should improve the selection of drug candidates and also reduce the likelihood of later candidate failure, by providing in vivo human ADME data, especially for pharmacokinetics and metabolism, at an earlier stage in drug development than is currently the case.
The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. [2019]The Northwick Park incident has focused the attention on the risk of healthy volunteers participating in Phase I First-in-Man (FiM) studies irrespective of biologicals or small molecules being applied. However, only few data on the safety of healthy volunteers receiving small molecules in FiM trials are available. This study reports on the safety of healthy volunteers participating in single dose FiM studies performed with small molecules at the Bayer in-house study ward in Wuppertal from 2000 to 2005.
Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]This report analyzes all adverse events (AEs) which occurred in healthy volunteers in a phase I center over a five-year period. It included 142 phase I studies with a total of 1,559 participants receiving 2,955 treatments with 32 different active drugs and placebo (ratio 6.5 : 1 in terms of follow-up days). The observation period covered a total of 29,664 follow-up days.
Healthy volunteer studies in toxicology. [2019]In the future there will be an increasing need for quantitative human risk assessment in order to develop soundly-based risk level regulations. Human volunteer studies can contribute to gain essential data needed for this risk assessment. Volunteer studies are especially relevant to study the biokinetics and metabolism of a compound. Comparison of these data with those of laboratory animals can increase the accuracy in extrapolation study results from animals to man. Furthermore, the results of volunteer studies can be used to fill in the gaps of knowledge which cannot be solved with in vitro or animal studies in order to develop adequate physiologically-based biokinetic or biodynamic models for human risk assessment.
Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. [2022]An understanding of the health of potential volunteers in Africa is essential for the safe and efficient conduct of clinical trials, particularly for trials of preventive technologies such as vaccines that enroll healthy individuals. Clinical safety laboratory values used for screening, enrolment and follow-up of African clinical trial volunteers have largely been based on values derived from industrialized countries in Europe and North America. This report describes baseline morbidity during recruitment for a multi-center, African laboratory reference intervals study.
Hip-Spine Relationship between Sagittal Balance of the Lumbo-Pelvi-Femoral Complex and Hip Extension Capacity: An EOS Evaluation in a Healthy Caucasian Population. [2023]A prospective study of healthy volunteers.