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Completed

NCT Number: NCT01262794

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

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Guildford, Surrey, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CDP6038

Biological

100 mg/mL solution for injection, single dose

Placebo

Biological

0.9% sodium chloride for injection Single-dose

Primary outcomes

  1. Maximum drug concentration (Cmax)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  2. 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

  3. 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

  4. Apparent volume of distribution (Vz/F)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  5. Apparent total body clearance (CL/F)

    Time frame: Multiple sampling from 0 to 113 days following single dose

  6. Terminal elimination half-life (T½)

    Time frame: Multiple sampling from 0 to 113 days following single dose

Secondary outcomes

  1. 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

  2. Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects

    Time frame: Multiple sampling from 0 to 15 weeks following single dose

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2010
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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