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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: CDP6038
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP6038 0.3 mg/kg<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection, single dose<br>|
| Experimental: CDP6038 1 mg/kg<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection, single dose<br>|
| Experimental: CDP6038 3 mg/kg<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection, single dose<br>|
| Experimental: CDP6038 6 mg/kg<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection, single dose<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* 0.9% sodium chloride for injection Single-dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Japanese