NCT02156375

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

June 3, 2014

Last Update Submit

March 21, 2016

Conditions

Healthy

Keywords

HealthyUstekinumabSTELARA®

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed plasma concentration of study drug.

    Day 0 through Day 113

  • Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])

    The AUC(0-inf) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.

    Day 0 through Day 113

Secondary Outcomes (6)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Baseline up to Day 141

  • Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])

    Day 0 through Day 113

  • Terminal half-life (T1/2)

    Day 0 through Day 113

  • Total systemic clearance (CL)

    Day 0 through Day 113

  • Volume of distribution (Vz)

    Day 0 through Day 113

  • +1 more secondary outcomes

Study Arms (2)

Ustekinumab 90 mg/mL

EXPERIMENTAL
Drug: Ustekinumab

Ustekinumab 5 mg/mL

EXPERIMENTAL
Drug: Ustekinumab

Interventions

UstekinumabDRUG

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.

Also known as: STELARA®
Ustekinumab 90 mg/mL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive and a body mass index (BMI) of 18.5 kilogram per square meter (kg/m\^2) to 29.0 kg/m\^2, inclusive
  • If a woman, she must be incapable of pregnancy or using a highly effective method of birth control
  • A woman must have a negative serum pregnancy test
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Are nonsmokers or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

You may not qualify if:

  • Participant currently has or has a history of any clinically significant medical illness or medical disorders including malignancy
  • Participant has previously received ustekinumab
  • Participant has a known or suspected intolerance or hypersensitivity to any biologic medication including ustekinumab
  • Participant has received an investigational drug within a specified period prior to the planned first dose of study drug or is currently enrolled in an investigational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Tempe, Arizona, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Neptune City, New Jersey, United States

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

US(3)