Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 2:38 AM
Study NCT ID:
NCT04507256
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
Sponsor:
AstraZeneca
Organization:
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 AZD7442's 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-003076-40 | EUDRACT_NUMBER | None | View |