jRCT2071200111已完成不适用
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- adverse event
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- •Negative results from both SARS-CoV-2 qRT-PCR and serology tests
- •Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators
排除标准
- •Fever above 37.5 degrees Celsius by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
- •History of infection with SARS or MERS
- •Any drug therapy within 7 days prior to Day 1
结局指标
主要结局
adverse event
时间窗: To evaluate the safety and tolerability of AZD7442 administered IV or IM to healthy participants 18 to 55 years of age.
adverse events, concomitant therapy, safety laboratory parameters (haematology, clinical chemistry, coagulation, and urinalysis); 12-lead ECG; vital signs, and physical examination.
Pharmacokinetics
时间窗: To evaluate Pharmacokinetics of AZD8895 and AZD1061 after single IV/IM administration of AZD7442.
After IV infusion: Ceoi, Cmax, Tmax, t1/2 z, AUClast, AUCinf, Vss, Vz and CL. After IM injection: Cmax, Tmax, t1/2 z, AUClast, AUCinf, extravascular systemic clearance (CL/F), bioavailability (F) and extravascular terminal phase volume of distribution (Vz/F).
次要结局
未报告次要终点
研究者
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