A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
NCT06081465 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2024-07-26
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
VG290131
The study drug and matching placebo will be administered orally.
Sponsors & Collaborators
-
Tigermed Consulting Co., Ltd
collaborator INDUSTRY -
Zhejiang Vimgreen Pharmaceuticals, Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-20
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Australia
Study Locations
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