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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01262794

Enrollment

Registered

2010-12-17

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy volunteers, Japanese

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

Interventions

BIOLOGICALCDP6038

100 mg/mL solution for injection, single dose

BIOLOGICALPlacebo

0.9% sodium chloride for injection Single-dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Terminal elimination half-life (T½)	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
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

Secondary

Measure	Time frame
Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects	Multiple sampling from 0 to 15 weeks following single dose
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026