A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02156375
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ustekinumab — DRUG
    Participants will receive a single 6 milligram per kilogram (mg/kg) intravenous infusion of 90 milligram per milliliter (mg/mL) liquid in vial (LIV) formulation, diluted in saline, on Day 1.
  • Ustekinumab — DRUG
    Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.

Study Details

The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.

Key Dates

Start date
May 31, 2014
Status verified
Mar 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ustekinumab 90 mg/mL
  • Experimental: Ustekinumab 5 mg/mL

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 0 through Day 113 ]

Locations (3)

FacilityCityStateZIPSite coordinators
-TempeArizona--
-LincolnNebraska--
-Neptune CityNew Jersey--

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