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.

Hibi Kazushige0 个研究点目标入组 40 人开始时间: 2021年3月10日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The safety and tolerability data over the study period (361 days) of AZD7442 300 mg IM, 600 mg IM, 300 mg IV and 1000 mg IV administration did not raise any safety concerns in healthy Japanese participants. - Overall, the PK analysis supports that the PK of AZD8895 and AZD1061 were similar and that these 2 antibodies followed linear kinetics. - ADA incidence was 6.7% (2 out of 30 participants), with no effect on the serum concentration of either AZD8895 or AZD1061.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 <= 55age old（—）
性别: All

入选标准

•1. Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
•2. Negative results from both SARS-CoV-2 qRT-PCR and serology tests
•3. Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators

排除标准

•1. 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.
•2. History of infection with SARS or MERS
•3. Any drug therapy within 7 days prior to Day 1

研究者

发起方

Hibi Kazushige

相似试验

已完成

3 期

Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient AdultsCOVID-19

NCT04723394AstraZeneca910

已完成

1 期

Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy VolunteersHealthy

NCT01037725AstraZeneca64

已完成

1 期

Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral DosesDiabetes Mellitus Type 2

NCT00841048AstraZeneca107

已完成

1 期

A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult PatientsTumorsCarcinomaCancer

NCT00613652AstraZeneca30

终止

1 期

Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female VolunteersHealthy Volunteers

NCT00736788AstraZeneca16