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Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106

Overweight and Obesity Clinical Trial

Official title:
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GMA106 IN HEALTHY, OVERWEIGHT AND OBESE ADULTS

Clinical Trial Summary

This will be a single centre, Phase 1, placebo-control, randomized, double-blind, sequential single and multiple ascending dose study to assess the safety, tolerability, and PK of GMA106 in healthy, overweight or obese subjects.

Clinical Trial Description

The objective of the study is to assess the safety, tolerability, and PK of single and multiple GMA106 SC injection. The study design is a standard design for this type of study. This SAD study will consist of 6 cohorts (1 cohort per dose level). Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive under fasting conditions, either the study drug GMA106, or matching placebo. In each cohort, 6 subjects will be administered GMA106 and 2 subjects will receive the matching placebo, for a total of 48 subjects planned for evaluation in this study. One randomization scheme will be produced for each cohort separately. There will be 3 cohorts in the MAD study. Dose groups in MAD are consisted of 20 mg, 40 mg and 80mg. Subjects will be dosed once a week in fasting conditions for 12 weeks. In 20 mg multiple doses group (Cohort 7), 4 subjects will be randomized in a 3:1 ratio to receive GMA106 or matching placebo throughout the course of 12 weeks. In 40 mg (Cohort 8) and 80 mg (Cohort 9) multiple doses groups, 7 subjects will be randomized in a 6:1 ratio, respectively. A total of 18 subjects planned for evaluation in the MAD study. A randomization system will be created for the MAD study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05054530
Study type Interventional
Source Gmax Biopharm LLC.
Contact
Status Completed
Phase Phase 1
Start date November 11, 2021
Completion date November 17, 2023
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