NCT03969849

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

A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Birch Pollen Allergy

Interventions

Type	Name	Description
DRUG	REGN5713-5714-5715	Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
DRUG	Matching placebo	Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose

Timeline

• Start date: 2019-06-03
• Primary completion: 2020-03-27
• Completion: 2020-03-27
• First posted: 2019-05-31
• Last updated: 2020-04-28

Locations

3 sites across 1 country: Belgium