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 Oct 2024 by AstraZeneca
AstraZeneca
-
The study will assess pharmacokinetic (PK) comparability between different formulations of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs), AZD8895 and AZD1061.
This is a randomized, open label, three-arm, single dose, parallel group, multi-center, PK comparability study. Eligible healthy participants will be randomized in a 1:1:1 ratio between the 3 treatment groups. Each participant will receive AZD7442 as either a single intramuscular (IM) dose (co-formulation; AZD8895 + AZD1061), or as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) from either clonal cell line material or cell pool material. Following an observation and PK and pharmacodynamic (PD) sample collection, post-dose, participants will be discharged from the Clinical Unit. During the Follow-up Period of approximately 1 year, participants will return as outpatient follow-up visits until Day 361. The total duration of the study for a participant will be approximately 389 days comprising of a Screening Period that can last up to 28 days, Treatment Period of 1 day, and a Follow up Period of 360 days.
Location
Location
Houston, TX, United States, 77058
Location
La Mesa, CA, United States, 91942
Location
Chula Vista, CA, United States, 91911
Location
Scottsdale, AZ, United States, 85260
Location
Lake Worth, FL, United States, 33462
Location
Berlin, NJ, United States, 08009
Location
Meridian, ID, United States, 83642
Location
North Hollywood, CA, United States, 91606
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. |
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