Clinical trial NCT01276119: The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: CDP6038
single-dose
pharmacokinetics
healthy subjects
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.


Eligibility criteria: 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

Primary outcomes:
measure: The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
timeFrame: Baseline to 14 weeks
measure: 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.
timeFrame: Baseline to 14 weeks
measure: The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.
timeFrame: Baseline to 14 weeks
measure: The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
timeFrame: Baseline to 14 weeks
measure: The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.
timeFrame: Baseline to 14 weeks
measure: Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
timeFrame: Baseline to 14 weeks
measure: 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.
timeFrame: Baseline to 14 weeks
Secondary outcomes:
measure: Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.
timeFrame: Baseline to 14 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: