NCT01262794

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2010

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

10 months

First QC Date

December 16, 2010

Last Update Submit

September 26, 2011

Conditions

Healthy Volunteers

Keywords

Healthy volunteersJapanese

Outcome Measures

Primary Outcomes (6)

  • Maximum drug concentration (Cmax)

    Multiple sampling from 0 to 113 days following single dose

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

    Multiple sampling from 0 to 113 days following single dose

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

    Multiple sampling from 0 to 113 days following single dose

  • Apparent volume of distribution (Vz/F)

    Multiple sampling from 0 to 113 days following single dose

  • Apparent total body clearance (CL/F)

    Multiple sampling from 0 to 113 days following single dose

  • Terminal elimination half-life (T½)

    Multiple sampling from 0 to 113 days following single dose

Secondary Outcomes (2)

  • 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

    Multiple sampling from 0 to 15 weeks following single dose

  • Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects

    Multiple sampling from 0 to 15 weeks following single dose

Study Arms (5)

CDP6038 0.3 mg/kg

EXPERIMENTAL
Biological: CDP6038

CDP6038 1 mg/kg

EXPERIMENTAL
Biological: CDP6038

CDP6038 3 mg/kg

EXPERIMENTAL
Biological: CDP6038

CDP6038 6 mg/kg

EXPERIMENTAL
Biological: CDP6038

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

CDP6038BIOLOGICAL

100 mg/mL solution for injection, single dose

CDP6038 0.3 mg/kgCDP6038 1 mg/kgCDP6038 3 mg/kgCDP6038 6 mg/kg
PlaceboBIOLOGICAL

0.9% sodium chloride for injection Single-dose

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese volunteers

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Guildford, Surrey, United Kingdom

Location

MeSH Terms

Interventions

olokizumab

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 17, 2010

Study Start

November 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

GB(1)