Study of MAR002 in Healthy Men

Marea Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Acromegaly

Treatments: Drug: Placebo; Drug: MAR002

Study type: Interventional

Funder types: Industry

Identifiers

NCT07195175

MAR-201

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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45 participants in 6 patient groups

Dose A MAR002

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Placebo

Drug: MAR002

Dose B MAR002

Experimental group

Description:

Cohort 2 receiving single Dose B

Treatment:

Drug: Placebo

Drug: MAR002

Dose C MAR002

Experimental group

Description:

Cohort 3 receiving single Dose C

Treatment:

Drug: Placebo

Drug: MAR002

Dose D MAR002

Experimental group

Description:

Cohort 4 receiving single Dose D

Treatment:

Drug: Placebo

Drug: MAR002

Dose E MAR002

Experimental group

Description:

Cohort 5 receiving single Dose E

Treatment:

Drug: Placebo

Drug: MAR002

Dose F MAR002

Experimental group

Description:

Cohort 6 receiving multiple Dose F

Treatment:

Drug: Placebo

Drug: MAR002