CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 82 enrolled
Drug / intervention
REGN1033 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02943239
NCT02943239Phase 1Completed

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

Regeneron Pharmaceuticals·interventional·Posted Oct 24, 2016·Updated Aug 9, 2024

In Brief

A Phase 1 clinical trial evaluating REGN1033, REGN2477, and 1 other intervention for Healthy Volunteers. Completed, enrolled 82 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 24, 2016
Enrollment StartDec 8, 2016
Primary CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.7 years ago

Interventions

REGN1033drug

REGN1033

REGN2477drug

REGN2477

Placeboother

Placebo