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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
Sponsor
AlphaMol Science Ltd. (Shanghai)
Phase
Phase 1
Started
2026-07-01
Last updated
2026-07-06

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality
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