Recruiting NCT07195175
Study of MAR002 in Healthy Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MAR002, Placebo.
- Who it may be relevant to
- Registry conditions: Acromegaly. Basic parameters: 18 years — 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men
Overview
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
Interventions
- Drug MAR002
subcutaneous injection - Drug Placebo
Subcutaneous injection
Primary outcome measures
- 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.]
Secondary outcome measures (6)
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Marea Site — Tempe
Identifiers
NCT: NCT07195175 · MAR-201