Trials / Completed
CompletedNCT06548945
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Gan and Lee Pharmaceuticals, USA · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GZR18 | 5 mg-maximum tolerated dose (MTD), single dose |
| OTHER | Placebo | administered the same volume as GZR18 |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2023-08-14
- Completion
- 2023-08-14
- First posted
- 2024-08-12
- Last updated
- 2024-08-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06548945. Inclusion in this directory is not an endorsement.