drugset / Trial / NCT03645746

Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

NCT03645746 ↗

Phase 1 Completed 56 enrolled Regeneron Pharmaceuticals
RandomizedSequentialQuadruple-blindBasic science

Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants. The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

Timeline

Start
2018-08-23
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NADECNEMAB Monoclonal antibody — Intravenous

Indications

No indication recorded.