Calendario›REGN›Pozelimab

Pozelimab

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

Ensayo de REGENERON PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

19

previstos

Centros

1

Fin del objetivo primario

jul 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2020.

Qué mide

Incidence and severity of treatment emergent adverse events (TEAEs) (del registro, en inglés) (hasta 20 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. The secondary objectives of the study are: * To assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart * To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart * To assess the immunogenicity of pozelimab and cemdisiran

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04601844), actualizada en nov 2021.