A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ustekinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01081704

CR016207

Details and patient eligibility

About

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

Full description

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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