drugset
drugset / Trial / NCT03320707

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants

NCT03320707 ↗

Phase 1 Completed 66 enrolled Janssen Research & Development, LLC
RandomizedSequentialDouble-blindOther

Summary

The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.

Timeline

Start
2017-10-16
Primary completion
2019-08-27
Completion
2019-08-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody — Subcutaneous
Background rHuPH20 Protein / enzyme biologic — Subcutaneous

Indications

No indication recorded.