Study of MAR002 in Healthy Men

NCT ID: NCT07195175

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-07-31

Brief Summary

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

Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose A MAR002

Subcutaneous injection

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Dose B MAR002

Cohort 2 receiving single Dose B

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Dose C MAR002

Cohort 3 receiving single Dose C

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Dose D MAR002

Cohort 4 receiving single Dose D

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Dose E MAR002

Cohort 5 receiving single Dose E

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Dose F MAR002

Cohort 6 receiving multiple Dose F

Group Type EXPERIMENTAL

MAR002

Intervention Type DRUG

subcutaneous injection

Placebo

Intervention Type DRUG

Subcutaneous injection

Interventions

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MAR002

subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Marea Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marea Site

Tempe, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew Lane

Role: CONTACT

415-766-3610

Other Identifiers

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MAR-201

Identifier Type: -

Identifier Source: org_study_id

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