drugset / Trial / NCT05375760

A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19

NCT05375760

Phase 2 Terminated 251 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelPrevention

Summary

A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19

Timeline

Start
2022-06-09
Primary completion
2023-10-04
Completion
2023-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject cilgavimab Monoclonal antibody 150 mg Intramuscular
Subject cilgavimab Monoclonal antibody 300 mg Intramuscular
Subject tixagevimab Monoclonal antibody 150 mg Intramuscular
Subject tixagevimab Monoclonal antibody 300 mg Intramuscular

Indications