The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Biological: CDP6038; Other: Placebo

• Registration Number: NCT01276119
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A, CDP6038 0.001 mg/kg, iv	CDP6038	-
Cohort B, CDP6038 0.01 mg/kg, iv	CDP6038	-
Cohort C, CDP6038 0.03 mg/kg, iv	CDP6038	-
Cohort D, CDP6038 0.1 mg/kg, iv	CDP6038	-
Cohort E, CDP6038 0.3 mg/kg, iv	CDP6038	-
Cohort G, CDP6038 1.0 mg/kg, iv	CDP6038	-
Cohort I, CDP6038 3.0 mg/kg, iv	CDP6038	-
Cohort K, CDP6038 10.0 mg/kg, iv	CDP6038	-
Cohort A, Placebo, iv	Placebo	-
Cohort B, C, D, E, G, I, K, Placebo, iv	Placebo	-
Cohort F, CDP6038 0.3 mg/kg, sc	CDP6038	-
Cohort H, CDP6038 1.0 mg/kg, sc	CDP6038	-
Cohort J, CDP6038 3.0 mg/kg, sc	CDP6038	-
Cohort F, H, J, Placebo, sc	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
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
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
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.	Baseline to 14 weeks
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.	Baseline to 14 weeks
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.	Baseline to 14 weeks
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

Secondary Outcome Measures

Name	Time	Method
Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.	Baseline to 14 weeks