Study of MAR002 in Healthy Men

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07195175

Enrollment

Registered

2025-09-26

Start date

2025-08-11

Completion date

2026-07-31

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men

Interventions

DRUGMAR002

subcutaneous injection

DRUGPlacebo

Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Randomized, Double-Blind (sponsor unblinded), placebo-controlled single ascending dose and multiple dose

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with TEAEs (treatment-emergent adverse events)	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men

Secondary

Measure	Time frame	Description
PK Parameters - Tmax	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (Tmax)
PK Parameters - AUC	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (AUC)
PK Parameters -- Cmax	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (Cmax)
PK Parameters - Clearance	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (Clearance)
PK Parameters - MRT	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (MRT)
PK Parameters - Half Life	From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.	To evaluate the PK parameters through plasma concentration (Half Life)

Countries

United States

Contacts

Primary ContactAndrew Lane

mar-201-info@mareatx.com415-766-3610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026