NCT01276119

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

January 11, 2011

Last Update Submit

March 21, 2012

Conditions

Pharmacokinetics

Keywords

CDP6038single-dosepharmacokineticshealthy subjects

Outcome Measures

Primary Outcomes (7)

  • The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.

    Baseline to 14 weeks

  • 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.

    Baseline to 14 weeks

  • The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.

    Baseline to 14 weeks

  • The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.

    Baseline to 14 weeks

  • The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.

    Baseline to 14 weeks

  • Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.

    Baseline to 14 weeks

  • 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.

    Baseline to 14 weeks

Secondary Outcomes (1)

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

    Baseline to 14 weeks

Study Arms (14)

Cohort A, CDP6038 0.001 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort B, CDP6038 0.01 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort C, CDP6038 0.03 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort D, CDP6038 0.1 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort E, CDP6038 0.3 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort G, CDP6038 1.0 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort I, CDP6038 3.0 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort K, CDP6038 10.0 mg/kg, iv

EXPERIMENTAL
Biological: CDP6038

Cohort A, Placebo, iv

PLACEBO COMPARATOR
Other: Placebo

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

PLACEBO COMPARATOR
Other: Placebo

Cohort F, CDP6038 0.3 mg/kg, sc

EXPERIMENTAL
Biological: CDP6038

Cohort H, CDP6038 1.0 mg/kg, sc

EXPERIMENTAL
Biological: CDP6038

Cohort J, CDP6038 3.0 mg/kg, sc

EXPERIMENTAL
Biological: CDP6038

Cohort F, H, J, Placebo, sc

PLACEBO COMPARATOR
Other: Placebo

Interventions

CDP6038BIOLOGICAL

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

Cohort A, CDP6038 0.001 mg/kg, iv
PlaceboOTHER

0.9% sodium chloride for injection Single infusion over 60 minutes

Cohort A, Placebo, iv

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, Germany

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

September 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

DE(1)