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REGN4461

A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers

Ensayo de REGENERON PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

113

previstos

Centros

1

Fin del objetivo primario

ene 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en abr 2018.

Qué mide

Number of treatment-emergent adverse events (TEAEs) (del registro, en inglés) (hasta la semana 27)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to: * Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile * Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants * Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants * Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time * Assess the immunogenicity of single and repeated doses of REGN4461

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03530514), actualizada en mar 2020.