NCT07230418

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	HRS-3095 Tablet	Oral HRS-3095 tablet.
DRUG	HRS-3095 Placebo Tablet	Oral HRS-3095 placebo tablet.

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-11-17
• Last updated: 2025-12-03

Locations

1 site across 1 country: China