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sotrovimab · COSMIC

Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

Ensayo de Vir Biotechnology, Inc. en COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 1

Estado

Interrumpido

Participantes

316

previstos

Centros

10

Fin del objetivo primario

abr 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.».

Qué mide

Part A (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab (Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. The study will be conducted in three parts (Part A, an optional Part B and Part C). Part B and Part C (cohort 2) were optional so they were not initiated. Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Más ensayos de VIR

Todos los de VIR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05280717), actualizada en abr 2024.