NCT02943239

Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: * Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume * Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition * Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033 * Assess immunogenicity of REGN2477 or REGN1033 * Assess REGN2477 or REGN1033 target engagement

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN1033	REGN1033
DRUG	REGN2477	REGN2477
OTHER	Placebo	Placebo

Timeline

• Start date: 2016-12-08
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2016-10-24
• Last updated: 2024-08-09

Locations

2 sites across 1 country: New Zealand