Study identifier:D8850C00009
ClinicalTrials.gov identifier:NCT05166421
EudraCT identifier:N/A
CTIS identifier:N/A
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
Corona virus disease
Phase 1
Yes
-
All
224
Interventional
18 Years - 79 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD7442 (co-formulation) Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1. | Biological/Vaccine: AZD7442 AZD7442 will be administered via IM route. |
Active Comparator: AZD8895 and AZD1061 (clonal cell line material) Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1. | Biological/Vaccine: AZD8895 (clonal cell line material) AZD8895 will be administered via IM route. Biological/Vaccine: AZD1061 (clonal cell line material) AZD1061 will be administered via IM route. |
Active Comparator: AZD8895 and AZD1061 (cell pool material) Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1. | Biological/Vaccine: AZD8895 (cell pool material) AZD8895 will be administered via IM route. Biological/Vaccine: AZD1061 (cell pool material) AZD1061 will be administered via IM route. |