A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
研究概览
简要总结
The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.
详细描述
This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 18 years
- •Subjects who are able and willing to provide the informed consent
- •Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.
排除标准
- •History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.
研究组 & 干预措施
Cohort 1
0.2 mg/kg UB-221 or placebo
干预措施: UB-221 (Drug)
Cohort2
0.6 mg/kg UB-221 or placebo
干预措施: UB-221 (Drug)
Cohort 3
2 mg/kg UB-221 or placebo
干预措施: UB-221 (Drug)
Cohort 4
6 mg/kg UB-221 or placebo
干预措施: UB-221 (Drug)
结局指标
主要结局
To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
时间窗: 99 days
1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS
次要结局
未报告次要终点