Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants

Study identifier:D8850C00009

ClinicalTrials.gov identifier:NCT05166421

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase 1, Randomized, Open label, Three-arm, Single Dose, Parallel Group Study to Compare AZD7442 (AZD8895 + AZD1061) Pharmacokinetic Exposure Following Intramuscular Administration as a Co-formulation versus Administration from Two Separate Vials of the Individual Monoclonal Antibodies in Adult Healthy Participants

Medical condition

Corona virus disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

224

Study type

Interventional

Age

18 Years - 79 Years

Date

Study Start Date: 30 Nov 2021
Primary Completion Date: 19 Jul 2023
Study Completion Date: 19 Jul 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria