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NCT Number: NCT07195175

Study of MAR002 in Healthy Men

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

Recruiting

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Marea Site

Tempe, Arizona, 85283, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to provide written informed consent
  • Age 18 to 40
  • Weight 55 to 95 kg
  • Body mass index (BMI) 18 to 30 kg/m2
  • Healthy men

Exclusion criteria

  • 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/C
  • History of substance abuse or nicotine use
  • Recent blood donation
  • History of pituitary disorder
  • Any condition that prevents the participant from complying with study procedures

Treatment and study plan

MAR002

Drug

subcutaneous injection

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Number of participants with TEAEs (treatment-emergent adverse events)

    Time frame: 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 outcomes

  1. PK Parameters -- Cmax

    Time frame: 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)

  2. PK Parameters - Tmax

    Time frame: 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)

  3. PK Parameters - AUC

    Time frame: 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)

  4. PK Parameters - Half Life

    Time frame: 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)

  5. PK Parameters - Clearance

    Time frame: 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)

  6. PK Parameters - MRT

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Lane

CONTACT

[email protected]

415-766-3610

Sponsors and collaborators

Lead sponsor

Marea Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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