A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Study Overview
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Brief Summary
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A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

Detailed Description
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This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.

Official Title
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A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ustekinumab
* Drug: ustekinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have no clinically relevant abnormalities Non smoker Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>ustekinumab Single dose of 45 mg subcutaneous injection | Drug: ustekinumab<br>* Single dose of 45 mg subcutaneous injection<br>|
| Experimental: 002<br>ustekinumab Single dose of 90 mg subcutaneous injection | Drug: ustekinumab<br>* Single dose of 90 mg subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants. |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer, Chinese male, Stelara