NCT05510843终止1 期
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety as assessed by the incidence and severity of adverse events
研究概览
简要总结
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Women and Men ages 18-75
- •Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
- •Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
- •Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
- •Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions
排除标准
- •A diagnosis of acute urticaria or non-cold chronic inducible urticaria
- •Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
- •A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
- •Clinical laboratory values outside of the normal ranges at the Screening visit
- •History of any clinically significant abnormality that would contraindicate participation
- •There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
研究组 & 干预措施
THB001 Dose Level A
Experimental
干预措施: THB001 (Drug)
THB001 Dose Level B
Experimental
干预措施: THB001 (Drug)
THB001 Dose Level C
Experimental
干预措施: THB001 (Drug)
结局指标
主要结局
Safety as assessed by the incidence and severity of adverse events
时间窗: From Day 1 through Week 12
Safety evaluations will include analyses of adverse events by treatment group
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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