drugset / Trial / NCT06081465
A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
Phase 1
Recruiting
86 enrolled
Zhejiang Vimgreen Pharmaceuticals, Ltd.
Tigermed Consulting Co., Ltd · collab
RandomizedSequentialDouble-blindOther
Summary
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.
Timeline
- Start
- 2023-10-20
- Primary completion
- 2024-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VG290131 | Unknown | 1 mg | Oral |
| Subject | VG290131 | Unknown | 5 mg | Oral |
| Subject | VG290131 | Unknown | 25 mg | Oral |
| Subject | VG290131 | Unknown | 50 mg | Oral |
| Subject | VG290131 | Unknown | 100 mg | Oral |
| Subject | VG290131 | Unknown | 200 mg | Oral |
Indications
No indication recorded.