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

Purpose

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

Condition	Intervention	Phase
Pharmacokinetics	Biological: CDP6038 Other: Placebo	Phase 1

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

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. [ Time Frame: Baseline to 14 weeks ] [ Designated as safety issue: No ]

Enrollment:	67
Study Start Date:	September 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort A, CDP6038 0.001 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 60 minutes
Experimental: Cohort B, CDP6038 0.01 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort C, CDP6038 0.03 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort D, CDP6038 0.1 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort E, CDP6038 0.3 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort G, CDP6038 1.0 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort I, CDP6038 3.0 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Experimental: Cohort K, CDP6038 10.0 mg/kg, iv	Biological: CDP6038 100 mg/mL solution for injection Single infusion over 120 minutes
Placebo Comparator: Cohort A, Placebo, iv	Other: Placebo 0.9% sodium chloride for injection Single infusion over 60 minutes
Placebo Comparator: Cohort B, C, D, E, G, I, K, Placebo, iv	Other: Placebo 0.9% sodium chloride for injection Single infusion over 120 minutes
Experimental: Cohort F, CDP6038 0.3 mg/kg, sc	Biological: CDP6038 100 mg/mL solution for injection Single sc injection
Experimental: Cohort H, CDP6038 1.0 mg/kg, sc	Biological: CDP6038 100 mg/mL solution for injection Single sc injection
Experimental: Cohort J, CDP6038 3.0 mg/kg, sc	Biological: CDP6038 100 mg/mL solution for injection Single sc injection
Placebo Comparator: Cohort F, H, J, Placebo, sc	Other: Placebo 0.9% sodium chloride for injection Single sc injection

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276119

Locations

Germany

Berlin, Germany

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01276119 History of Changes
Other Study ID Numbers:	RA0001
Study First Received:	January 11, 2011
Last Updated:	March 21, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by UCB, Inc.:

CDP6038
single-dose
pharmacokinetics
healthy subjects

ClinicalTrials.gov processed this record on May 22, 2013