A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Sponsor
Centocor, Inc.
Study ID
NCT01081704
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • ustekinumab — DRUG
    Single dose of 45 mg subcutaneous injection
  • ustekinumab — DRUG
    Single dose of 90 mg subcutaneous injection

Study Details

A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

Key Dates

Start date
Oct 31, 2009
Status verified
May 2014
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

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

Arms

  • Experimental: 001
    ustekinumab Single dose of 45 mg subcutaneous injection
  • Experimental: 002
    ustekinumab Single dose of 90 mg subcutaneous injection

Primary Outcome Measure

Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants. [ Time Frame: Week 16 ]

Related Studies