A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
NCT07230418 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-12-03
Summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
Conditions
Interventions
- DRUG
-
HRS-3095 Tablet
Oral HRS-3095 tablet.
- DRUG
-
HRS-3095 Placebo Tablet
Oral HRS-3095 placebo tablet.
Sponsors & Collaborators
-
Chengdu Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-10
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
Countries
- China
Study Locations
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