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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01276119
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Biological: CDP6038 Other: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2008
Primary Completion Date : October 2009
Study Completion Date : October 2009
Arms and Interventions

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
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ]
  5. The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ]
  6. Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ]
  7. 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 ]

Secondary Outcome Measures :
  1. Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. [ Time Frame: Baseline to 14 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276119


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

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01276119     History of Changes
Other Study ID Numbers: RA0001
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by UCB Pharma:
CDP6038
single-dose
pharmacokinetics
healthy subjects