Calendario›REGN›Pozelimab

Pozelimab

A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers

Ensayo de REGENERON PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

30

previstos

Centros

1

Fin del objetivo primario

jun 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2021.

Qué mide

Concentrations of pozelimab in serum over time (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 assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and 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 evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04940364), actualizada en jul 2022.