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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: CDP6038; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Biological: Placebo; 0.9% sodium chloride for injection Single-dose
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 16, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (ESTIMATE): December 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2011
• Last Update Submitted That Met QC Criteria: September 26, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Healthy volunteers; Japanese
• Other Study ID Numbers: RA0074; 2010-022543-38 (EUDRACT_NUMBER)