Pharmacokinetics Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single-dose, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects
Verified date | March 2012 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
Status | Completed |
Enrollment | 67 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Body mass index between 19.0 and 28.0 kg/m² and body weight between = 50 kg and = 120 kg Exclusion Criteria: - Previous trial participation or blood donation/loss within 3 months - Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical) - Plans for or actual vaccination within 3 months - Previous drug treatments - Tobacco use or heavy caffeine consumption - Systolic blood pressure <90 or >145mmHg, diastolic blood pressure <40 or >90mmHg or heart rate <45 or >90 beats per minute |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
UCB Pharma |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Primary | PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects. | Baseline to 14 weeks | No | |
Secondary | Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. | Baseline to 14 weeks | No |
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