A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adverse event and serious adverse event
研究概览
简要总结
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.
详细描述
Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.
Randomization of approximately 40 Japanese participants is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •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°C 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 and serious adverse event
时间窗: Up to Day361
To evaluate the safety and tolerability of AZD7442 administered IV or IM_Adverse event and serious adverse event
Pharmacokinetics - Serum Concentration
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Area under the plasma concentration-time curve to the last measurable time point
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Maximum Serum Concentration
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Time to Maximum Serum Concentration
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics -extravascular terminal phase volume of distribution
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - extravascular systemic clearance
时间窗: Up to 361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics -bioavailability
时间窗: Up to Day361
To evaluate the single-dose PK of AZD7442.
次要结局
- The serum neutralizing responses against SARS-CoV-2 using Geometric mean fold rise from baseline(Up to Day361)
- ADA responses to the AZD7442 in serum.(Up to Day361)
- The serum neutralizing responses against SARS-CoV-2 using Geometric mean titre from baseline(Up to Day361)