NCT01081704

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

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

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

February 25, 2010

Last Update Submit

May 26, 2014

Conditions

Healthy

Keywords

Healthy volunteerChinese maleStelara

Outcome Measures

Primary Outcomes (1)

  • Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.

    Week 16

Secondary Outcomes (2)

  • Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events

    Week 16

  • Immune response (immunogenicity) of ustekinumab

    Week 16

Study Arms (2)

001

EXPERIMENTAL

ustekinumab Single dose of 45 mg subcutaneous injection

Drug: ustekinumab

002

EXPERIMENTAL

ustekinumab Single dose of 90 mg subcutaneous injection

Drug: ustekinumab

Interventions

ustekinumabDRUG

Single dose of 45 mg subcutaneous injection

001

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have no clinically relevant abnormalities
  • Non smoker

You may not qualify if:

  • Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Have any underlying physical or psychological medical condition
  • Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

  • Zhu Y, Wang Q, Frederick B, Bouman-Thio E, Marini JC, Keen M, Petty KJ, Davis HM, Zhou H. Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies. Clin Drug Investig. 2013 Apr;33(4):291-301. doi: 10.1007/s40261-013-0072-2.

    PMID: 23512638DERIVED

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    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

February 25, 2010

First Posted

March 5, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

CN(1)