NCT03320707

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

A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Daratumumab	Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
DRUG	Placebo	Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
DRUG	rHuPH20	Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.

Timeline

• Start date: 2017-10-16
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2017-10-25
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study