CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
AZD7442 +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04507256
NCT04507256Phase 1Completed
CompareCT.gov

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults

AstraZeneca·interventional·Posted Aug 11, 2020·Updated Oct 18, 2024

In Brief

A Phase 1 clinical trial evaluating AZD7442 and Placebo for COVID-19. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited Kingdom
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 11, 2020
Enrollment StartAug 18, 2020
Primary CompletionOct 19, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago

Interventions

AZD7442combination

Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4.

Placeboother

Participants randomised to placebo will receive the same volume of solution as participants on active treatment.