A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Phase 1 Completed 30 enrolled Janssen Research & Development, LLC

Non-randomizedSequentialOpen-labelBasic science

Summary

The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.

Timeline

Start: 2022-05-30
Primary completion: 2022-09-09
Completion: 2022-09-09

Publications

Li H, Liu J, Wang X, Zhao W, Zhang L, Niu X, Liu J, Dong Z. Pharmacokinetics, Pharmacodynamics, and Safety of Nipocalimab in Healthy Chinese Volunteers: A Single-Dose, Phase I Study. Neurol Ther. 2025 Aug;14(4):1439-1450. doi: 10.1007/s40120-025-00763-5. Epub 2025 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nipocalimab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Nipocalimab	Monoclonal antibody	30 mg/kg	Intravenous
Subject	Nipocalimab	Monoclonal antibody	45 mg/kg	Intravenous

Indications

No indication recorded.