A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Adverse Events of Special Interest
研究概览
简要总结
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).
详细描述
A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, 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
- •Adults ≥ 18 years
- •Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
- •Healthy or medically stable participants
- •Contraceptive within 365 days post dosing
排除标准
- •Medical condition:
- •Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
- •Acute illness including fever on the day prior to or day of dosing.
- •Any other significant disease increase the risk to participant study.
- •Laboratory related:
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome).
- •Serum creatinine > 176 μmol/L.
- •Haemoglobin < 10g/dL.
- •Platelet count < 100 × 10^3/μL.
- •White blood cell count < 3.5 × 10^3/μL or neutrophil count < 1.5 × 10^3/μL.
- •Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
- •COVID-19 infection history/any receipt of mAb indicated for COVID-
- •Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1
研究组 & 干预措施
AZD7442
co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
干预措施: 600 mg AZD7442 IV (Drug)
Placebo
co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.
干预措施: 600mg placebo IV (Drug)
结局指标
主要结局
Adverse Events of Special Interest
时间窗: recorded from the time of signature of the ICF up to 245 days
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
次要结局
- Serum Concentrations of AZD7442 Over Time(recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.)