drugset / Trial / NCT07684560

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).

NCT07684560 ↗

Phase 1 Not yet recruiting 48 enrolled AlphaMol Science Ltd. (Shanghai)
RandomizedSequentialQuadruple-blindOther

Summary

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.

Timeline

Start
2026-07-01
Primary completion
2027-03-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha-0261 Unknown 50 mg Oral
Subject Alpha-0261 Unknown 125 mg Oral
Subject Alpha-0261 Unknown 250 mg Oral
Subject Alpha-0261 Unknown 500 mg Oral