NCT04691180已完成1 期
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of subjects with SAEs
研究概览
简要总结
This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be 18 to 49 years of age inclusive
- •Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2 (inclusive).
- •Male or female
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation.
- •A history of significant hypersensitivity, intolerance, or allergy to any drug compound
- •History of alcohol or other substance abuse
研究组 & 干预措施
Cohort 1
Experimental
BRII-196 and BRII-198 dose level 1 or placebo
干预措施: BRII-196 and BRII-198 (Drug)
Cohort 1
Experimental
BRII-196 and BRII-198 dose level 1 or placebo
干预措施: Placebo (Drug)
Cohort 2
Experimental
BRII-196 and BRII-198 dose level 2 or placebo
干预措施: BRII-196 and BRII-198 (Drug)
Cohort 2
Experimental
BRII-196 and BRII-198 dose level 2 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with SAEs
时间窗: up to 24 weeks
Incidence of adverse events (AEs) by CTCAE v5.0
时间窗: up to 24 weeks
次要结局
- Mean of change from pre-dose baseline in RBC count(up to 24 weeks)
- Mean of change from pre-dose baseline in WBC count.(up to 24 weeks)
- Proportion of subjects with hypersensitivity reactions(up to 24 weeks)
- Serum Concentration of BRII-196 and BRII-198(up to 24 weeks)
- Proportion of subjects with infusion-related reactions(up to 24 weeks)
- Mean of change from pre-dose baseline in ECG readings(up to 24 weeks)
- Mean of change from pre-dose baseline in Platelets count(up to 24 weeks)
- Mean of change from pre-dose baseline in Hemoglobin result(up to 24 weeks)
研究者
研究点 (1)
Loading locations...
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