Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507256
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2020-08-07
Brief Title:
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Double-blind Placebo-controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2024-10
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:
In this first-in-humans dose escalation study AZD7442 AZD8895 AZD1061 will be evaluated for safety tolerability pharmacokinetics and generation of anti-drug antibodies ADAs The study is intended to enable future studies of AZD7442s efficacy in preventing and treating COVID-19
Detailed Description:
This is a Phase I first time in human randomised double-blind placebo-controlled and dose escalation study
The study will comprise of
1 A Screening Period of up to 27 days Day -28 through Day -2
2 A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 1 day before Investigational Medicinal Product IMP administration on Day 1 until at least 24 hours after IMP administration will be discharged on Day 2 after all safety evaluations have been completed and
3 A Follow up Period lasting 360 days through to Day 361 after the IMP dose
The study will be conducted at a single study centre in United Kingdom
The study will comprise of
1 A Screening Period of up to 27 days Day -28 through Day -2
2 A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 1 day before Investigational Medicinal Product IMP administration on Day 1 until at least 24 hours after IMP administration will be discharged on Day 2 after all safety evaluations have been completed and
3 A Follow up Period lasting 360 days through to Day 361 after the IMP dose
The study will be conducted at a single study centre in United Kingdom
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