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

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Biological: CDP6038; Biological: CDP6038; Biological: CDP6038; Other: Placebo; Other: Placebo; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A, CDP6038 0.001 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort B, CDP6038 0.01 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort C, CDP6038 0.03 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort D, CDP6038 0.1 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort E, CDP6038 0.3 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort G, CDP6038 1.0 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort I, CDP6038 3.0 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort K, CDP6038 10.0 mg/kg, iv	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Placebo Comparator: Cohort A, Placebo, iv	Other: Placebo; 0.9% sodium chloride for injection Single infusion over 60 minutes; Other: Placebo; 0.9% sodium chloride for injection Single infusion over 120 minutes; Other: Placebo; 0.9% sodium chloride for injection Single sc injection
Placebo Comparator: Cohort B, C, D, E, G, I, K, Placebo, iv	Other: Placebo; 0.9% sodium chloride for injection Single infusion over 60 minutes; Other: Placebo; 0.9% sodium chloride for injection Single infusion over 120 minutes; Other: Placebo; 0.9% sodium chloride for injection Single sc injection
Experimental: Cohort F, CDP6038 0.3 mg/kg, sc	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort H, CDP6038 1.0 mg/kg, sc	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Experimental: Cohort J, CDP6038 3.0 mg/kg, sc	Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 60 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single infusion over 120 minutes; Biological: CDP6038; 100 mg/mL solution for injection Single sc injection
Placebo Comparator: Cohort F, H, J, Placebo, sc	Other: Placebo; 0.9% sodium chloride for injection Single infusion over 60 minutes; Other: Placebo; 0.9% sodium chloride for injection Single infusion over 120 minutes; Other: Placebo; 0.9% sodium chloride for injection Single sc injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; healthy subjects; single-dose; CDP6038
• Other Study ID Numbers: RA0001