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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Able to comprehend and willing to sign an informed consent form (ICF);
• Male and female healthy subjects with an age range between 18 and 55 years (inclusive);
• Body mass index between 18.0 and 32.0 kg/m2 (inclusive), and the body weight is ≥ 50 kg for men and ≥ 45 kg for women;
• For healthy subjects, no clinically significant abnormalities;
• Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
Locations
Other Locations
China
The Frist Clinical Medicial College of Qingdao University
RECRUITING
Qingdao
Contact Information
Primary
Hongda Lin
hongda.lin@hengrui.com
+86-0518-82342973
Backup
Yifan Li
yifan.li@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2026-02
Participants
Target number of participants: 66
Treatments
Experimental: HRS-3095 Group
Placebo_comparator: HRS-3095 Placebo Group
Related Therapeutic Areas
Sponsors
Leads: Chengdu Suncadia Medicine Co., Ltd.