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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |