NCT05996380

A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes

A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single-dose escalation trial was designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg, 100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.

Conditions

• T2DM

Interventions

Type	Name	Description
DRUG	SHR-3167	SHR-3167, Single administration
DRUG	SHR-3167 Placebo	SHR-3167 Placebo Single administration

Timeline

• Start date: 2023-06-09
• Primary completion: 2024-01-25
• Completion: 2024-04-28
• First posted: 2023-08-18
• Last updated: 2023-10-11

Locations

1 site across 1 country: China