A Study of TG103 in Chinese Healthy Adult Subjects

Phase 1 Completed 32 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

RandomizedParallel-groupDouble-blindBasic science

Summary

The main purposes of this study are to determine: 1. To assess the safety and tolerability of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects. 2. The pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects were assessed.

Timeline

Start: 2019-07-29
Primary completion: 2020-11-11
Completion: 2020-11-11

Publications

Jin J, Cui G, Mi N, Wu W, Zhang X, Xiao C, Wang J, Qiu X, Han M, Li Z, Wang L, Lu T, Niu H, Wu Z, Li J. Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. Eur J Pharm Sci. 2023 Jun 1;185:106448. doi: 10.1016/j.ejps.2023.106448. Epub 2023 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TG103	Protein / enzyme biologic	3 mg	Subcutaneous
Subject	TG103	Protein / enzyme biologic	7.5 mg	Subcutaneous
Subject	TG103	Protein / enzyme biologic	15 mg	Subcutaneous
Subject	TG103	Protein / enzyme biologic	22.5 mg	Subcutaneous

Indications

No indication recorded.