NCT07195175

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2025Jul 2026

Study Start

First participant enrolled

August 11, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

August 27, 2025

Last Update Submit

January 8, 2026

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

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

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

    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.

Secondary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +1 more secondary outcomes

Study Arms (6)

Dose A MAR002

EXPERIMENTAL

Subcutaneous injection

Drug: MAR002Drug: Placebo

Dose B MAR002

EXPERIMENTAL

Cohort 2 receiving single Dose B

Drug: MAR002Drug: Placebo

Dose C MAR002

EXPERIMENTAL

Cohort 3 receiving single Dose C

Drug: MAR002Drug: Placebo

Dose D MAR002

EXPERIMENTAL

Cohort 4 receiving single Dose D

Drug: MAR002Drug: Placebo

Dose E MAR002

EXPERIMENTAL

Cohort 5 receiving single Dose E

Drug: MAR002Drug: Placebo

Dose F MAR002

EXPERIMENTAL

Cohort 6 receiving multiple Dose F

Drug: MAR002Drug: Placebo

Interventions

PlaceboDRUG

Subcutaneous injection

Dose A MAR002Dose B MAR002Dose C MAR002Dose D MAR002Dose E MAR002Dose F MAR002
MAR002DRUG

subcutaneous injection

Dose A MAR002Dose B MAR002Dose C MAR002Dose D MAR002Dose E MAR002Dose F MAR002

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marea Site

Tempe, Arizona, 85283, United States

RECRUITING

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Central Study Contacts

Andrew Lane

CONTACT

415-766-3610mar-201-info@mareatx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Randomized, Double-Blind (sponsor unblinded), placebo-controlled single ascending dose and multiple dose
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 26, 2025

Study Start

August 11, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)