drugset / Trial / 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

NCT05996380

Phase 1 Unknown 52 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-06-09
Primary completion
2024-01-25
Completion
2024-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR-3167 Unknown 0.5 mg Subcutaneous
Subject SHR-3167 Unknown 2 mg Subcutaneous
Subject SHR-3167 Unknown 8 mg Subcutaneous
Subject SHR-3167 Unknown 25 mg Subcutaneous
Subject SHR-3167 Unknown 50 mg Subcutaneous
Subject SHR-3167 Unknown 100 mg Subcutaneous
Subject SHR-3167 Unknown 150 mg Subcutaneous