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

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01276119
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 14
• Duration (Months): 13
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Biological: CDP6038; Biological: CDP6038; Biological: CDP6038; Other: Placebo; Other: Placebo; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

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. [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. [Baseline to 14 weeks]

4. The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [Baseline to 14 weeks]

5. The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. [Baseline to 14 weeks]

6. Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. [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. [Baseline to 14 weeks]

Secondary Outcome Measures

1. Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. [Baseline to 14 weeks]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01276119
• Other Study ID Numbers: RA0001
• First Posted: Jan 13, 2011
• Last Update Posted: Mar 22, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by UCB Pharma: CDP6038; single-dose; pharmacokinetics; healthy subjects

Study Results

No Results Posted as of Mar 22, 2012