Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).

This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with chronic spontaneous urticaria.

NCT Number	NCT07684560
Lead Sponsor	AlphaMol Science Ltd. (Shanghai)
Conditions	Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Enrollment	48 participants
Start Date	2026-07-01
Primary Completion	2027-03-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-06