drugset / Trial / NCT03530514

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

NCT03530514

Phase 1 Completed 113 enrolled Regeneron Pharmaceuticals
RandomizedSequentialTriple-blindBasic science

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

Timeline

Start
2018-04-24
Primary completion
2020-01-27
Completion
2020-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Mibavademab Monoclonal antibody Intravenous

Indications

No indication recorded.