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.
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.