A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Centocor, Inc.
- Enrollment
- 24
- Primary Endpoint
- Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
Study Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.
Detailed 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 golimumab (Simponi). The study population will consist of 24 healthy male participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a subcutaneous injection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have no clinically relevant abnormalities
- •non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.
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.
Arms & Interventions
001
Golimumab Single dose of 50 mg subcutaneously
Intervention: Golimumab (Drug)
002
Golimumab Single dose of 100 mg subcutaneously
Intervention: Golimumab (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
Time Frame: Day 71 (Week 11)
Secondary Outcomes
- Number of participants with adverse events(Day 71)
- Immunogenicity of golimumab, as measured by antibodies to golimumab(Day 71)