Overview

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

Status:
Completed
Trial end date:
2020-03-27
Target enrollment:
Participant gender:
Summary
The 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.
Phase:
Phase 1
Details
Lead Sponsor:
Regeneron Pharmaceuticals