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.
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)
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)
Sequential
Alpha-0261
DrugOral, tablet
Placebo
Other interventionOral, tablet
Frequency of treatment emergent adverse events
Incidence, severity and relationship to study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1)
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
Pharmacokinetics Cmax (Part 2)
Cmax: Maximum Plasma Concentration
Pharmacokinetics AUC (part 2)
AUC: Area Under the Concentration-time Curve
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