Clinical Trial

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

Completed Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-13; most recent amendment 2026-06-10.
Status change: Recruiting → Completed 2026-06-10
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT07230418
Lead Sponsor Chengdu Suncadia Medicine Co., Ltd.
Conditions Chronic Spontaneous Urticaria
Enrollment 82 participants
Start Date 2025-11-10
Primary Completion 2026-04-19 (estimated)
Study Completion 2026-04-19 (estimated)
Updated on ClinicalTrials.gov 2026-06-12