Trials / Completed
CompletedNCT05611281
GS3-007a Oral Solution in Healthy Subjects
Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
Detailed description
This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication | The dosage was calculated according to body weight and dose group once a day according to the assigned group. |
Timeline
- Start date
- 2022-09-22
- Primary completion
- 2023-04-01
- Completion
- 2023-04-01
- First posted
- 2022-11-10
- Last updated
- 2023-04-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05611281. Inclusion in this directory is not an endorsement.