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).
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |