NCT04790006

A Study of TG103 in Subjects With Type 2 Diabetes

A Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Ascending Dose Phase Ib Study in Subjects With Type 2 Diabetes to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TG103 Injection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes.

Detailed description

This study is a randomized, double-blind, placebo-controlled, multicenter, dose-escalating study to characterize the safety (including the anti-drug antibodies(ADA)), tolerability pharmacokinetics (PK) and pharmacodynamic parameters（PD）of TG103. The study will consist of 3 periods: an approximately 2-week lead-in period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Three dose groups (7.5mg, 15mg and 22.5mg) of subjects will be enrolled and dosed sequentially; 12

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	TG103	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-03-10
• Last updated: 2021-03-10