LAD603 for Healthy Adults
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Almirall, S.A.
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called LAD603 in healthy adults to see if it is safe and how the body handles it. Researchers will give different doses to check for side effects and how the drug is processed.
Do I have to stop taking my current medications for this trial?
Yes, you must stop taking any medications, including over-the-counter ones, at least 14 days before the trial starts, unless the investigator decides they won't interfere with the study. Hormonal contraceptives and acetaminophen (up to 2 grams per day) are exceptions.
What data supports the idea that LAD603 for Healthy Adults is an effective drug?
The available research does not provide specific data on LAD603 for Healthy Adults. Instead, it focuses on other treatments for rheumatoid arthritis, such as upadacitinib and tofacitinib. Upadacitinib showed improvements in patient-reported outcomes, indicating it might be effective for those who did not respond well to other drugs. However, there is no direct information on LAD603's effectiveness.12345
What safety data exists for the treatment LAD603?
The provided research does not contain specific safety data for LAD603. It discusses safety data related to antihypertensive trials, adverse drug reactions in older adults, and safety-related drug label changes for cardiometabolic agents, but none of these directly mention LAD603 or provide safety data for it.678910
Is the treatment LAD603 a promising treatment for healthy adults?
The information provided does not directly mention LAD603 or its effects. However, it discusses the benefits of omega-3 fatty acids, which are known to improve muscle strength and reduce inflammation in older adults. If LAD603 is related to omega-3 fatty acids, it might be promising for improving muscle function and reducing inflammation.1112131415
Eligibility Criteria
This trial is for healthy adults who can participate in a study to assess the safety and effects of a new medication, LAD603. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.Inclusion Criteria
I am willing to join the study and have signed all necessary consent forms.
My BMI is between 18.5 and 29.9, and I weigh at least 60 kg.
I am a male who has had a vasectomy or will use contraception and avoid sperm donation during the study.
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Exclusion Criteria
I have had cancer or a related disease in the last 5 years, except for certain skin cancers or cervical cancer in situ that were successfully treated.
I have a history of tuberculosis or have been in close contact with someone who has active tuberculosis.
My heart rate or blood pressure readings were abnormal during my initial check-up.
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Treatment Details
Interventions
- LAD603 (Monoclonal Antibodies)
Trial OverviewThe study is testing LAD603 against a placebo to see how safe it is and how the body responds to different doses. It's divided into two parts: one where subjects receive a single dose, and another with multiple doses over time.
Participant Groups
14Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: (LAD603) Cohort DExperimental Treatment1 Intervention
Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.
Group II: Part 2: (LAD603) Cohort CExperimental Treatment1 Intervention
Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.
Group III: Part 2: (LAD603) Cohort BExperimental Treatment1 Intervention
Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.
Group IV: Part 2: (LAD603) Cohort AExperimental Treatment1 Intervention
Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.
Group V: Part 1: (LAD603) Cohort 8Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group VI: Part 1: (LAD603) Cohort 7Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group VII: Part 1: (LAD603) Cohort 6Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group VIII: Part 1: (LAD603) Cohort 5Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group IX: Part 1: (LAD603) Cohort 4Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group X: Part 1: (LAD603) Cohort 3Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group XI: Part 1: (LAD603) Cohort 2Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group XII: Part 1: (LAD603) Cohort 1Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD603 SC injection on Day 1.
Group XIII: Part 2: PlaceboPlacebo Group1 Intervention
Participants will receive multiple ascending dose of matching placebo SC injection on Days 1, 8 15, and 22.
Group XIV: Part 1: PlaceboPlacebo Group1 Intervention
Participants will receive single ascending dose of matching placebo SC injection on Day 1.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ICON Phase 1 unit LenexaLenexa, KS
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Who Is Running the Clinical Trial?
Almirall, S.A.Lead Sponsor
References
Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. [2023]Patient-reported outcomes (PROs) are important when evaluating treatment benefits in rheumatoid arthritis (RA). We compared upadacitinib, an oral, selective JAK-1 inhibitor, with placebo to assess clinically meaningful improvements in PROs in patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR).
Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. [2020]Optimal targeted treatment in rheumatoid arthritis requires early identification of failure to respond. This post hoc analysis explored the relationship between early disease activity changes and the achievement of low disease activity (LDA) and remission targets with tofacitinib.
Estimates of minimal clinically important improvments vary with the responsiveness of the sample. [2023]Minimal clinically important improvements (MCII) are known to vary with the baseline level in the sample. We examined if MCIIs are also larger in samples with higher responsiveness.
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. [2022]The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome tool recommended for the assessment of disease activity in patients with rheumatoid arthritis (RA) in clinical practice. This analysis evaluated the long-term effect of upadacitinib vs. comparators on RAPID3 scores in patients with RA in the phase 3 SELECT clinical trial program.
Estimation of the minimal clinically important difference on the Aberrant Behaviour Checklist-Irritability (ABC-I) for people with intellectual disabilities who display aggressive challenging behaviour: A triangulated approach. [2022]The minimal clinically important difference (MCID) is relevant in the estimation of improvement in a patient outcome.
Representativeness of antihypertensive trials: analysis of serious adverse events. [2023]Context: Representativeness of 'standard' antihypertensive drug trials is uncertain, with limited recruitment of older people. Some trials specifically recruit older participants to address this. Trials are obliged to report hospitalizations and deaths, regardless of cause, as Serious Adverse Events (SAEs). If older-people's trials are representative, we would expect rates of SAEs in trials to be similar to the rate of hospitalisation and death in the community, and higher than standard trials. Objective: To compare the rate of SAEs in hypertension trials to rates of hospitalisation and death among people taking similar treatments in the community. Study Design: Observational study comparing trial populations to a community cohort. Dataset: We identified trials of Renin-Angiotensin-Aldosterone system (RAAS) drugs for hypertension from clinicatrials.gov. We identified a community comparison population of people with hypertension starting RAAS drugs using primary care data from the Wales, UK (SAIL databank). Population studied: Trial participants from 110 RAAS hypertension trials (11 older-people's trials, mean age 73, and 99 standard trials, mean age 56). Community cohort of people with hypertension (n=56,036, mean age 60) starting RAAS drugs. Outcomes: SAEs in trials (mostly accounted for by hospitalizations or deaths) and all-cause hospitalizations/deaths in the community comparison. SAE rates in older-people and standard trials were compared, adjusting for trial characteristics. The community rate was used to calculate the expected rate of hospitalizations/deaths given the age/sex distribution of each trial. We then compared the expected rate with the observed rate of SAEs in each trial. Results: Older-people's trials had higher SAEs rate than standard trials (0.18 versus 0.11 events/person/year, adjusted IRR 1.74, 95% CI 1.03-2.92). The hospitalisation and death rate in the community for those taking RAAS antihypertensives was much greater than the rate of SAEs reported in standard (ratio 3.70 (3.12-4.55)) and older-people's trials (4.35 (2.56-7.69)), adjusting for age and sex. Conclusion: Trials report substantially fewer SAEs than expected from rates of hospitalisations and deaths among similar-aged people receiving equivalent treatments in the community. SAE rates may be a useful metric to assess trial representativeness. Clinicians should be cautious when applying trial recommendations to older people, even when trials focus on older people.
Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices. [2023]Older adults are more prone to develop adverse drug reactions (ADRs) since they exhibit numerous risk factors. The first aim was to analyse the number of spontaneous ADR reports regarding older adults (> 65) in the ADR database of the German Federal Institute for Drugs and Medical Devices (BfArM) and to set them in relation to i) the number of ADR reports concerning younger adults (19-65), and ii) the number of inhabitants and assumed drug-exposed inhabitants. The second aim was to analyse, if reported characteristics occurred more often in older vs. younger adults.
Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports. [2023]Selective safety data collection may simplify late-stage clinical trials and improve their feasibility. However, the impact on increasing overall drug safety knowledge is unknown. The aim of this study is to evaluate how much safety information is added to the drug label based on large trials after initial authorization. Changes made to the "undesirable effects" section of the drug label of cardiometabolic agents approved between 2000 and 2020 based on the results of large (> 1,000 patient) clinical trials submitted to the European Medicines Agency (EMA) were evaluated. The study focused on glucose lowering, antithrombotic, and lipid-modifying agents. The primary outcome was the number of changes in adverse drug reactions in the drug label. The EMA reviewed 55 large trials concerning 25 cardiometabolic agents after the initial marketing authorization, which included 402,444 patients. Ultimately, 38 trials (69%) resulted in a safety section update, whereas 17 trials (31%) did not. Changes in listed adverse drug reactions were made following 19 trials (35%) for 12 agents: 77 adverse drug reactions were added, 11 were deleted, and the frequencies of 43 were changed. Most changes in adverse drug reactions arose from trials with antithrombotic agents (88%) and trials performed in a new population (92%). Large trials for cardiometabolic agents reported after authorization add limited new safety information on adverse drug reactions, especially when performed in the population studied prior to approval. This suggests that selective safety data collection does not reduce learnings from late stage cardiometabolic trials in populations comprehensively studied before.
Effectiveness and safety of colistin among older adults: a systematic review and meta-analysis. [2022]Limited data are available to guide colistin use in older adults (>65 years old). We aimed to assess the effectiveness and safety of colistin in this population.
Adverse drug reactions in older Australians, 1981-2002. [2020]To examine trends in adverse drug reactions (ADRs) in people aged 60 years or over causing admission to or an extended stay in Western Australian hospitals between 1981 and 2002.
Effect of dietary omega-3 fatty acid supplementation on frailty-related phenotypes in older adults: a systematic review and meta-analysis protocol. [2021]The beneficial effect of dietary omega-3 supplementation in younger adults or older people with acute or chronic disease is established. Knowledge is now needed about the effect in medically stable older people. The objective of this study is to examine and assess the evidence for a role of dietary omega-3 polyunsaturated fatty acid (PUFA) supplementation in older adults on (1) muscle mass and muscle strength, (2) inflammatory biomarkers and (3) physical activity.
A Randomized Trial of the Effects of Dietary n3-PUFAs on Skeletal Muscle Function and Acute Exercise Response in Healthy Older Adults. [2023]Skeletal muscle is critical for maintaining mobility, independence, and metabolic health in older adults. However, a common feature of aging is the progressive loss of skeletal muscle mass and function, which is often accompanied by mitochondrial impairments, oxidative stress, and insulin resistance. Exercise improves muscle strength, mitochondrial health, and cardiorespiratory fitness, but older adults often exhibit attenuated anabolic responses to acute exercise. Chronic inflammation associated with aging may contribute to this "anabolic resistance" and therapeutic interventions that target inflammation may improve exercise responsiveness. To this end, we conducted a randomized controlled trial to determine the effect of 6 months of dietary omega-3 polyunsaturated fatty acids (n3-PUFA) supplementation on skeletal muscle function (mass, strength), mitochondrial physiology (respiration, ATP production, ROS generation), and acute exercise responsiveness at the level of the muscle (fractional synthesis rate) and the whole-body (amino acid kinetics) in healthy older adults. When compared with a corn oil placebo (n = 33; 71.5 ± 4.8 years), older adults treated with 4 g/day n3-PUFA (n = 30; 71.4 ± 4.5 years) exhibited modest but significant increases in muscle strength (3.1 ± 14.7% increase in placebo vs. 7.5 ± 14.1% increase in n3-PUFA; p = 0.039). These improvements in muscle strength with n3-PUFA supplementation occurred in the absence of any effects on mitochondrial function and a minor attenuation of the acute response to exercise compared to placebo. Together, these data suggest modest benefits of dietary n3-PUFAs to muscle function in healthy older adults. Future studies may elucidate whether n3-PUFA supplementation improves the exercise response in elderly individuals with co-morbidities, such as chronic inflammatory disease or sarcopenia.
Relationship between sarcopenic obesity-related phenotypes and inflammatory markers in postmenopausal women. [2022]Ageing is associated with changes in body composition that may result in sarcopenic obesity (SO). Interleukin-6 (IL-6) and C-reactive protein (CRP) are important inflammatory markers related to ageing. SO has been examined as an important public health problem, but its association with inflammatory markers has yet to be investigated. The aim of this study was to investigate the association between SO-related phenotypes and inflammatory markers in postmenopausal women. A total of 130 women (66·7 ± 5·2 years) underwent body composition evaluation using dual-energy X-ray absorptiometry. Volunteers were classified according to a SO definition previously described in the literature. Waist circumference (WC) and handgrip strength (HG) were also measured. Blood samples were collected for CRP, tumour necrosis factor and IL-6 measurements. All the inflammatory markers were higher in SO individuals when compared to non-SO; however, only IL-6 reached statistical significance (median 3·34 versus 1·37 pg ml-1 ; P<0·05). Also, CRP was significantly correlated (P<0·01) with body mass index (rs  = 0·34), fat mass (FM; rs  = 0·25) and WC (rs  = 0·33). Similarly, IL-6 levels were significantly correlated (P<0·05) to age (rs  = 0·19), FM (rs  = 0·19) and WC (rs  = 0·17). HG was found to be significantly reduced among subjects with higher IL-6 levels (P = 0·02). In summary, the combination of reduced muscle mass and excess body fat (i.e. SO) is associated with elevated inflammatory markers in postmenopausal women. Moreover, CRP and IL-6 are associated with SO-related phenotypes in this population.
IL-6 gene variation is not associated with increased serum levels of IL-6, muscle, weakness, or frailty in older women. [2022]Elevated levels of the inflammatory cytokine IL-6 are associated with the development of disability, frailty, and mortality in older adults. These outcomes are likely mediated through inflammatory activity that alters hormones, skeletal muscle, and the immune system. Polymorphic variants in the IL-6 gene influence IL-6 expression. We hypothesized that IL-6 alleles associate with increased serum of IL-6, decreased muscle strength, and frailty, and tested this in the Women's Health and Aging cohorts. We genotyped 463 participants age 70-79, and identified three common IL-6 haplotype blocks for the Caucasian (n=363) and African American (n=100) subsets. Using linear and logistic regression, and adjusting for age, BMI, race, and osteoarthritis, we identified no significant or clinically meaningful relationship between any single IL-6 single nucleotide polymorphism (SNP) or any IL-6 haplotype and serum IL-6 level, grip, knee, or hip strength, or frailty. Given that the promoter SNP (rs1800795) has been reported to influence IL-6 levels and health outcomes, we performed a similar association study in the In Chianti population (n=266) and confirmed lack of association. These results suggest that IL-6 gene variation may not be an important factor in the determination of elevated IL-6 levels and related phenotypes found in older women.
Accumulation of polyunsaturated fatty acid-derived metabolites in the sarcopenic muscle of aging mice. [2023]Although it is known that advanced age alters skeletal muscle lipid metabolism, the role(s) of polyunsaturated fatty acid-derived metabolites (mostly eicosanoids and docosanoids) in sarcopenia are not clear. We therefore examined the changes in the metabolites of arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid in the sarcopenic muscle of aged mice.