A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mibavademab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.