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).

Официальное название

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Oral Doses of Alpha-0261 Tablets in Patients With Chronic Spontaneous Urticaria, and the Effect of Food in Healthy Participants.

Обзор

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.

Вмешательства

• Препарат Alpha-0261
  Oral, tablet
• Другое Placebo
  Oral, tablet

Первичные конечные точки

• Frequency of treatment emergent adverse events [Срок оценки: Part 1: approximately 6 weeks Part 2: approximately 1 week]

Вторичные конечные точки (3)

• Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1) [Срок оценки: From enrollment to the end of treatment at 4 weeks.]
• Pharmacokinetics Cmax (Part 2) [Срок оценки: From enrollment to end of follow-up visit, up to approximately 1 week.]
• Pharmacokinetics AUC (part 2) [Срок оценки: From enrollment to end of follow-up visit, up to approximately 1 week.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07684560 · Alpha-0261-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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