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REGN5713-5714-5715

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

Ensayo de REGENERON PHARMACEUTICALS, INC. en Healthy Volunteers · Birch Pollen Allergy (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

96

previstos

Centros

3

Fin del objetivo primario

mar 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2019.

Qué mide

Incidence and severity of treatment-emergent adverse events (TEAEs) (del registro, en inglés) (hasta 16 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 REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: * To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults * To assess the immunogenicity of single dose of REGN5713-5714-5715. In Part B: * To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715 * To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03969849), actualizada en abr 2020.