A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of participants with abnormal Coagulation test results
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
详细描述
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 to 55 years of age
- •Healthy by medical history, physical examination, and baseline safety laboratory tests
- •Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
- •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) > upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) > 1.5 × ULN
- •Serum creatinine > ULN
- •Haemoglobin < lower limit normal (LLN)
- •Platelet count < LLN
- •White blood cell or neutrophil count outside normal reference ranges
- •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.
研究组 & 干预措施
300 mg AZD7442 IM
Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
干预措施: AZD7442 IM (Drug)
300mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
干预措施: Placebo IM (Drug)
600 mg AZD7442 IM
Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
干预措施: AZD7442 IM (Drug)
600mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
干预措施: Placebo IM (Drug)
300 mg AZD7442 IV
co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
干预措施: AZD7442 IV (Drug)
300mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
干预措施: Placebo IV (Drug)
600 mg AZD7442 IV
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: AZD7442 IV (Drug)
600mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
干预措施: Placebo IV (Drug)
结局指标
主要结局
Number of participants with abnormal Coagulation test results
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of international normalised ratio (INR).
Number of participants with abnormal laboratory test results
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of albumin.
Incidence of adverse events (AEs)
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Incidence of serious adverse events (SAEs)
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Number of participants with abnormal urinalysis
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of glucose, protein, and blood.
Incidence of adverse event of special interests (AESIs)
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Number of participants with abnormal ECG readings
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
Results for heart rate will be analyzed.
Number of participants with abnormal vital signs
时间窗: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of body temperature (in degree Celsius).
次要结局
未报告次要终点