NCT06864507

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with chronic spontaneous urticaria.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	HS-10561	Single and multiple doses of HS-10561 orally
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-09-27
• Completion: 2026-12-31
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: China