MAR002 in healthy men

First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men

This trial tests whether a subcutaneous injection of MAR002 is safe and tolerable in healthy men aged 18 to 40.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Male
• Sponsor: Marea Therapeutics (Industry-sponsored)
• Locations: 1 site (Tempe, Arizona)
• Trial ID: NCT07195175 on ClinicalTrials.gov

What this trial studies

MAR002 is given by subcutaneous injection to healthy male volunteers in a Phase 1 interventional trial to characterize safety and tolerability. Eligible participants who meet weight and BMI requirements will be randomized to receive MAR002 or placebo and will undergo clinical monitoring, laboratory testing, and adverse event reporting. Key exclusion criteria include prior pituitary disorders, recent acute illness or blood donation, positive HIV/hepatitis tests, substance or nicotine use, and a history of cancer. The single-site study is sponsored by Marea Therapeutics and conducted in Tempe, Arizona.

Who should consider this trial

Good fit: Healthy men aged 18–40 years, weighing 55–95 kg with BMI 18–30 kg/m2 and no significant medical history, are the intended participants.

Not a fit: Women and people with pituitary disease, active infections, recent investigational drug exposure, substance or nicotine use, or a history of cancer are unlikely to be eligible or to receive direct benefit from this Phase 1 safety study.

Why it matters

Potential benefit: If MAR002 is shown to be safe in healthy volunteers, it could enable further testing that might lead to a new treatment option for people with acromegaly.

How similar studies have performed: Monoclonal antibody approaches have been applied to endocrine disorders with some success, but MAR002 is a novel agent with limited public clinical data.

Eligibility criteria

Inclusion Criteria:

1. Willingness to provide written informed consent
2. Age 18 to 40
3. Weight 55 to 95 kg
4. Body mass index (BMI) 18 to 30 kg/m2
5. Healthy men

Exclusion Criteria:

1. History of hypersensitivity to monoclonal antibodies or study drug
2. Participation in any other investigational drug study
3. History of cancer
4. Recent acute illness
5. Positive test for HIV, hepatitis B/C
6. History of substance abuse or nicotine use
7. Recent blood donation
8. History of pituitary disorder
9. Any condition that prevents the participant from complying with study procedures

Where this trial is running

Tempe, Arizona

• Marea Site — Tempe, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Andrew Lane

Conditions Acromegaly