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

Pharmacokinetics Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276119
• Other study ID #: RA0001
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2011
• Last updated: March 21, 2012
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Biological:
• CDP6038
100 mg/mL solution for injection Single infusion over 60 minutes
• CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
• CDP6038
100 mg/mL solution for injection Single sc injection

Other:
• Placebo
0.9% sodium chloride for injection Single infusion over 60 minutes
• Placebo
0.9% sodium chloride for injection Single infusion over 120 minutes
• Placebo
0.9% sodium chloride for injection Single sc injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.		Baseline to 14 weeks	No
Primary	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.		Baseline to 14 weeks	No
Primary	The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.		Baseline to 14 weeks	No
Primary	The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.		Baseline to 14 weeks	No
Primary	The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.		Baseline to 14 weeks	No
Primary	Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.		Baseline to 14 weeks	No
Primary	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.		Baseline to 14 weeks	No
Secondary	Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.		Baseline to 14 weeks	No