Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with clinical laboratory abnormalities
研究概览
简要总结
The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it:
- Safe
- Well tolerated
- Does the body absorb and eliminate HIB210 as expected
详细描述
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MAD HIB210
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
干预措施: HIB210 (Drug)
MAD Placebo
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with clinical laboratory abnormalities
时间窗: Baseline to End of Study (Up to Day 114)
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Baseline to End of Study (Up to Day 114)
Number of participants with vital sign abnormalities
时间窗: Baseline to End of Study (Up to Day 114)
Number of participants with physical examination abnormalities
时间窗: Baseline to End of Study (Up to Day 114)
Number of participants with adverse events
时间窗: Baseline to End of Study (Up to Day 114)
次要结局
- PK Parameters: tmax(Baseline to Day 29)
- Anti-drug Antibodies (ADA)(Baseline to End of Study (Up to Day 114))
- PK Parameters: Cmax(Baseline to Day 29)
- PK Parameters: AUC(Baseline to Day 29)