NCT07684560尚未招募1 期
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.
AlphaMol Science Ltd. (Shanghai)1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Frequency of treatment emergent adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •In general good health. (Part 2)
排除标准
- •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)
结局指标
主要结局
Frequency of treatment emergent adverse events
时间窗: 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.
次要结局
- Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (Part 1)(From enrollment to the end of treatment at 4 weeks.)
- Pharmacokinetics Cmax (Part 2)(From enrollment to end of follow-up visit, up to approximately 1 week.)
- Pharmacokinetics AUC (part 2)(From enrollment to end of follow-up visit, up to approximately 1 week.)
研究者
研究点 (1)
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