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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03320707
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 16, 2017
Status verified
Jan 2025
Primary completion
Aug 27, 2019
Completion
Aug 27, 2019

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Daratumumab
    Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20).
  • Placebo Comparator: Placebo
    Participants will receive placebo as a single SC dose in each of first 7 cohorts.

Primary Outcome Measure

Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo [ Time Frame: Up to Day 141 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

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By research site
Celerion· Tempe, AZ

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