drugset / Trial / NCT06556641
A Clinical Study of GZR33 and GZR101 in Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection. Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.
Timeline
- Start
- 2022-12-17
- Primary completion
- 2023-02-03
- Completion
- 2023-02-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GZR101 | Unknown | — | Subcutaneous |
| Subject | GZR33 | Unknown | — | Subcutaneous |
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.