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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: CDP6038; Biological: Placebo

• Registration Number: NCT01262794
• Lead Sponsor: UCB Pharma

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy Japanese volunteers

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDP6038 0.3 mg/kg	CDP6038	-
CDP6038 1 mg/kg	CDP6038	-
CDP6038 3 mg/kg	CDP6038	-
CDP6038 6 mg/kg	CDP6038	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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