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drugset / Trial / NCT04616105

Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers

NCT04616105 ↗

Phase 1 Terminated 19 enrolled Regeneron Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants The secondary objectives of the study are: * To characterize the pharmacokinetic (PK) profile of single SC and IV doses of REGN6490 in healthy first-generation Japanese adult participants * Assess immunogenicity of REGN6490 in healthy first-generation Japanese adult participants dosed with a single IV or SC dose of REGN6490

Timeline

Start
2020-11-18
Primary completion
2021-05-28
Completion
2021-05-28

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject REGN6490 Unknown — Subcutaneous

Indications

No indication recorded.