NCT04848558

A Study of Nipocalimab in Healthy Male and Female Participants

A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nipocalimab	Participants will receive IV infusion or SC injection of nipocalimab.
OTHER	Placebo	Participants will receive IV infusion or SC injection of placebo.

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-05-26
• Completion: 2022-05-26
• First posted: 2021-04-19
• Last updated: 2023-07-03

Locations

1 site across 1 country: Netherlands