NCT07116889进行中（未招募）1 期
A Phase 1 First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GB-0895 in Adults With Mild to Moderate Asthma or Single Dose in Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
- 试验地点
- 13
- 主要终点
- Number of participants with treatment related adverse events as assessed by CTCAE 5.0
研究概览
简要总结
This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A: Single Ascending Dose (SAD) (asthma participants)
Experimental
randomized 3:1 active:placebo
干预措施: GB-0895 (SC) (Biological)
Part A: Single Ascending Dose (SAD) (asthma participants)
Experimental
randomized 3:1 active:placebo
干预措施: Placebo (SC) (Drug)
Part B: Multiple Ascending Dose (MAD) (asthma participants)
Experimental
randomized 3:1 active:placebo
干预措施: GB-0895 (SC) (Biological)
Part B: Multiple Ascending Dose (MAD) (asthma participants)
Experimental
randomized 3:1 active:placebo
干预措施: Placebo (SC) (Drug)
Part C: Single Dose (COPD participants)
Experimental
randomized 3:1 active:placebo
干预措施: GB-0895 (SC) (Biological)
Part C: Single Dose (COPD participants)
Experimental
randomized 3:1 active:placebo
干预措施: Placebo (SC) (Drug)
结局指标
主要结局
Number of participants with treatment related adverse events as assessed by CTCAE 5.0
时间窗: Day 1 to Day 500
次要结局
- Measure of maximum plasma concentration of GB-0895(Day 1 to Day 500)
- Blood eosinophil counts(Day 1 to Day 500)
- Total exposure of GB-0895 (AUC)(Day 1 to Day 500)
- Incidence of treatment-emergent anti-drug antibody (ADA) response(Day 1 to Day 500)
研究者
研究点 (13)
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