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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
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
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.
Official title: A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-11-10
Completion Date
2026-02
Last Updated
2025-12-03
Healthy Volunteers
Yes
Conditions
Interventions
HRS-3095 Tablet
Oral HRS-3095 tablet.
HRS-3095 Placebo Tablet
Oral HRS-3095 placebo tablet.
Locations (1)
The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, China