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CompletedNCT01276119Updated Mar 22, 2012

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

A Phase 1 interventional study of CDP6038 and CDP6038 in Pharmacokinetics, sponsored by UCB Pharma. Completed at 1 site in Germany. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by UCB Pharma · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Pharmacokinetics

Keywords

  • CDP6038
  • single-dose
  • pharmacokinetics
  • healthy subjects
03

In context

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Cohort A, CDP6038 0.001 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort B, CDP6038 0.01 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort C, CDP6038 0.03 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort D, CDP6038 0.1 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort E, CDP6038 0.3 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort G, CDP6038 1.0 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort I, CDP6038 3.0 mg/kg, iv

    Biological: CDP6038

  • Experimental
    Cohort K, CDP6038 10.0 mg/kg, iv

    Biological: CDP6038

  • Placebo comparator
    Cohort A, Placebo, iv

    Other: Placebo

  • Placebo comparator
    Cohort B, C, D, E, G, I, K, Placebo, iv

    Other: Placebo

  • Experimental
    Cohort F, CDP6038 0.3 mg/kg, sc

    Biological: CDP6038

  • Experimental
    Cohort H, CDP6038 1.0 mg/kg, sc

    Biological: CDP6038

  • Experimental
    Cohort J, CDP6038 3.0 mg/kg, sc

    Biological: CDP6038

  • Placebo comparator
    Cohort F, H, J, Placebo, sc

    Other: Placebo

Interventions

  • BiologicalCDP6038

    100 mg/mL solution for injection Single infusion over 60 minutes

  • BiologicalCDP6038

    100 mg/mL solution for injection Single infusion over 120 minutes

  • BiologicalCDP6038

    100 mg/mL solution for injection Single sc injection

  • OtherPlacebo

    0.9% sodium chloride for injection Single infusion over 60 minutes

  • OtherPlacebo

    0.9% sodium chloride for injection Single infusion over 120 minutes

  • OtherPlacebo

    0.9% sodium chloride for injection Single sc injection

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.

    Time frame: Baseline to 14 weeks

07

Study locations

1 site
  • Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01276119
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Jan 13, 2011
Start date
Sep 2008
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Mar 22, 2012

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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