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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01262794
First received: December 16, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Biological: CDP6038
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Maximum drug concentration (Cmax) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CL/F) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (T½) [ Time Frame: Multiple sampling from 0 to 113 days following single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects [ Time Frame: Multiple sampling from 0 to 15 weeks following single dose ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP6038 0.3 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 1 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 3 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Experimental: CDP6038 6 mg/kg Biological: CDP6038
100 mg/mL solution for injection, single dose
Placebo Comparator: Placebo Biological: Placebo
0.9% sodium chloride for injection Single-dose

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese volunteers

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262794

Locations
United Kingdom
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01262794     History of Changes
Other Study ID Numbers: RA0074, 2010-022543-38
Study First Received: December 16, 2010
Last Updated: September 26, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Healthy volunteers
Japanese

ClinicalTrials.gov processed this record on August 26, 2014