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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01276119
First received: January 11, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Biological: CDP6038
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A, CDP6038 0.001 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 60 minutes
Experimental: Cohort B, CDP6038 0.01 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort C, CDP6038 0.03 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort D, CDP6038 0.1 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort E, CDP6038 0.3 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort G, CDP6038 1.0 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort I, CDP6038 3.0 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort K, CDP6038 10.0 mg/kg, iv Biological: CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Placebo Comparator: Cohort A, Placebo, iv Other: Placebo
0.9% sodium chloride for injection Single infusion over 60 minutes
Placebo Comparator: Cohort B, C, D, E, G, I, K, Placebo, iv Other: Placebo
0.9% sodium chloride for injection Single infusion over 120 minutes
Experimental: Cohort F, CDP6038 0.3 mg/kg, sc 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 sc injection
Experimental: Cohort J, CDP6038 3.0 mg/kg, sc 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 sc injection

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276119

Locations
Germany
Berlin, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01276119     History of Changes
Other Study ID Numbers: RA0001
Study First Received: January 11, 2011
Last Updated: March 21, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by UCB, Inc.:
CDP6038
single-dose
pharmacokinetics
healthy subjects

ClinicalTrials.gov processed this record on April 16, 2014