NCT05054530

Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Gmax Biopharm Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	GMA106 Injection	GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.
DRUG	GMA106 Matching Placebo	Matching Placebo for GMA106

Timeline

• Start date: 2021-11-11
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2021-09-23
• Last updated: 2024-01-30

Locations

1 site across 1 country: Australia