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CompletedNCT01262794Updated Sep 27, 2011

Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

A Phase 1 interventional study of CDP6038 and Placebo in Healthy Volunteers, sponsored by UCB Pharma. Completed at 1 site in United Kingdom. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-27.

Sponsored by UCB Pharma · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Male
01

Study summary

To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy volunteers
  • Japanese
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
20 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Japanese volunteers

Exclusion criteria

Exclusion Criteria:

  • Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
  • Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    CDP6038 0.3 mg/kg

    Biological: CDP6038

  • Experimental
    CDP6038 1 mg/kg

    Biological: CDP6038

  • Experimental
    CDP6038 3 mg/kg

    Biological: CDP6038

  • Experimental
    CDP6038 6 mg/kg

    Biological: CDP6038

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalCDP6038

    100 mg/mL solution for injection, single dose

  • BiologicalPlacebo

    0.9% sodium chloride for injection Single-dose

06

What researchers measure

Primary outcomes

  1. Maximum drug concentration (Cmax)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  2. Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  3. Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  4. Apparent volume of distribution (Vz/F)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  5. Apparent total body clearance (CL/F)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  6. Terminal elimination half-life (T½)

    Time frame: Multiple sampling from 0 to 113 days following single dose

Secondary outcomes

  1. PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects

    Time frame: Multiple sampling from 0 to 15 weeks following single dose

  2. Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects

    Time frame: Multiple sampling from 0 to 15 weeks following single dose

07

Study locations

1 site
  • Guildford, Surrey, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01262794
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Dec 17, 2010
Start date
Nov 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 27, 2011

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 ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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