Skip to main content
OpenTrials
Completed

NCT Number: NCT01276119

The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg

Exclusion criteria

  • Previous trial participation or blood donation/loss within 3 months
  • Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
  • Plans for or actual vaccination within 3 months
  • Previous drug treatments
  • Tobacco use or heavy caffeine consumption
  • Systolic blood pressure <90 or >145mmHg, diastolic blood pressure <40 or >90mmHg or heart rate <45 or >90 beats per minute

Treatment and study plan

CDP6038

Biological

100 mg/mL solution for injection Single infusion over 60 minutes

Placebo

Other

0.9% sodium chloride for injection Single infusion over 60 minutes

Primary outcomes

  1. The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  2. The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  3. The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  4. The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  5. The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  6. Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

  7. PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects.

    Time frame: Baseline to 14 weeks

Secondary outcomes

  1. Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.

    Time frame: Baseline to 14 weeks

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, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2011
Registry last updated
Mar 22, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.