NCT03530514

A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, And Pharmacodynamics of Single and Multiple Doses of REGN4461 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to: * Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile * Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants * Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants * Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time * Assess the immunogenicity of single and repeated doses of REGN4461

Detailed description

This is a 2-part study of the safety, tolerability, PK and pharmacodynamic (PD) of single and repeated doses of REGN4461 in healthy participants. In Part A, healthy lean or overweight participants will be enrolled to evaluate the safety, tolerability, PK, and PD of single ascending intravenous (IV) and subcutaneous (SC) doses. Interim PK and safety information from Part A will be used to select the dose level, frequency, and mode of administration (IV or SC) for repeat dosing in Part B. In Part B, overweight/obese participants with body mass index (BMI) 25-40 kg/m2 will be enrolled to evaluate the safety, tolerability, PK, and PD of repeated doses of REGN4461 in 4 distinct cohorts defined by baseline leptin levels.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN4461	REGN4461
DRUG	Placebo	Placebo-matching REGN4461

Timeline

• Start date: 2018-04-24
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2018-05-21
• Last updated: 2020-03-09

Locations

1 site across 1 country: Belgium