Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896541
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2021-02-26
Brief Title:
Phase I Double-blind Placebo-controlled Study of AZD7442
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Double-blind Placebo-controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 countriesregions with over 7800 million confirmed cases reported and more than 171 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 viruss receptor binding domain which enables the virus to bind to receptors on human cells By targeting this region of the viruss spike protein antibodies can block the viruss 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
Randomization of approximately 40 Japanese participants is planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None