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

Phase 1 Completed 224 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2021-11-30
Primary completion: 2023-07-19
Completion: 2023-07-19

Outcome

Mixed primary results

paper Pharmacokinetic comparability for tixagevimab, cilgavimab and AZD7442 was demonstrated between treatments PMID 41917376 ↗

paper where the lower 90% CI bound for AUClast GMR (0.7933) was slightly below the pre-defined threshold of 0.8000 PMID 41917376 ↗

Publications

Zhang H, Tang W, Sadow S, Baronio R, Tullio AN, Hirao L, Dzutseva V, Chen CC, Kiazand A, Chang LJ, Cohen TS, Gibbs M. Pharmacokinetic Comparability Assessment of Tixagevimab and Cilgavimab Developed for COVID-19 Prevention and Treatment Using Standard Exposure Metrics and Partial Area Under the Curve. Clin Pharmacokinet. 2026 May;65(5):747-761. doi: 10.1007/s40262-026-01631-7. Epub 2026 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD7442	Monoclonal antibody	300 mg	Intramuscular
Comparator	cilgavimab	Monoclonal antibody	150 mg	Intramuscular
Comparator	tixagevimab	Monoclonal antibody	150 mg	Intramuscular