Actively Recruiting
First in Human, Randomized, Blinded, Placebo-Controlled Single and Multiple Dose Study of MAR002 in Healthy Men
Led by Marea Therapeutics · Updated on 2026-01-12
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of MAR002, a drug given by subcutaneous injection, in healthy men aged 18 to 40 years. This phase 1 trial aims to understand how the body handles MAR002 and to monitor any treatment-emergent adverse events. The study focuses on healthy adult males, with measurements taken to assess the drug's pharmacokinetics and safety. Participants are assigned randomly to receive either different single doses (Dose B, C, D, or E) or multiple doses (Dose F) of MAR002, or a placebo, all given by subcutaneous injection. The study includes several cohorts, each receiving a specific dosing schedule. The trial uses a triple-blinded design to ensure objective results. During the study, participants will be monitored for adverse events and undergo pharmacokinetic assessments including drug concentration peaks, clearance, and half-life. Follow-up visits occur until Day 64 for early cohorts and Day 169 for later cohorts. The total duration depends on the assigned cohort schedule. Safety and drug behavior in the body are the primary focus throughout the study period.
CONDITIONS
Brief Title
Study of MAR002 in Healthy Men
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to provide written informed consent
- Age 18 to 40 years
- Weight between 55 and 95 kilograms
- Body mass index (BMI) between 18 and 30 kg/m2
- Healthy men
You will not qualify if you...
- History of hypersensitivity to monoclonal antibodies or study drug
- Participation in any other investigational drug study
- History of cancer
- Recent acute illness
- Positive test for HIV, hepatitis B, or hepatitis C
- History of substance abuse or nicotine use
- Recent blood donation
- History of pituitary disorder
- Any condition that prevents compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 169 days depending on cohort
Participants receive subcutaneous injections of either MAR002 or placebo in single or multiple doses depending on their cohort assignment.
Multiple visits for dosing and assessments over the treatment period
Duration - Up to 169 days depending on cohort
Participants are monitored for safety and pharmacokinetic outcomes after the last dose until the end of the study.
Scheduled visits for safety and pharmacokinetic evaluations
Trial Site Locations
Total: 1 location
1
Marea Site
Tempe, Arizona, United States, 85283
Actively Recruiting
Research Team
A
Andrew Lane
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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