Clinical Trials in China / NCT07684560
Starting soon
Phase 1
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 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Spontaneous Urticaria (CSU)Healthy Volunteers
Investigational drug(s) / intervention(s)
Alpha-0261 →Placebo
Alpha-0261: Oral, tablet
Placebo: Oral, tablet
Study 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.
Eligibility
Inclusion Criteria:
* Written informed consent must be obtained before any assessment is performed.(Part 1 and Part 2)
* Aged ≥ 18 and ≤ 75, male or female (Part 1).
* Diagnosed with CSU prior to screening at least 6 months. (Part 1)
* Received stable second-generation H1 antihistamine therapy for at least 2 weeks before randomization, and is willing to maintain the stable treatment regimen throughout the study treatment period. (Part 1)
* Aged ≥ 18 and ≤ 55, male or female (Part 2).
* Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2. (Part 2)
* In general good health. (Part 2)
Exclusion Criteria:
* Inducible urticaria with identifiable triggers, including dermographism, cold contact urticaria, heat contact urticaria, solar urticaria, pressure urticaria, delayed pressure urticaria, aquagenic urticaria, cholinergic urticaria, or contact urticaria. (Part 1)
* Other chronic pruritic skin diseases that may affect the assessment of study outcomes, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. (Part 1)
* Other conditions that may cause urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria. (Part 1)
* Have a history of any severe allergic reaction or anaphylaxis. (Part 2)
* Any condition, which in the investigator's opinion might jeopardize articipant's safety or compliance with the protocol. (Part 2)
* Have clinically significant abnormalities on clinical laboratory results. (Part 2)
Primary outcome measure(s)
- Frequency of treatment emergent adverse events — Part 1: approximately 6 weeks Part 2: approximately 1 week
Incidence, severity and relationship to study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07684560 on ClinicalTrials.gov ↗ ← All trials in China