Healthy Volunteers Clinical Trial
Official title:
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
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
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. ;
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