The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
NCT ID: NCT01276119
Last Updated: 2012-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
67 participants
INTERVENTIONAL
2008-09-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Cohort A, CDP6038 0.001 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 60 minutes
Cohort B, CDP6038 0.01 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort C, CDP6038 0.03 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort D, CDP6038 0.1 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort E, CDP6038 0.3 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort G, CDP6038 1.0 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort I, CDP6038 3.0 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort K, CDP6038 10.0 mg/kg, iv
CDP6038
100 mg/mL solution for injection Single infusion over 120 minutes
Cohort A, Placebo, iv
Placebo
0.9% sodium chloride for injection Single infusion over 60 minutes
Cohort B, C, D, E, G, I, K, Placebo, iv
Placebo
0.9% sodium chloride for injection Single infusion over 120 minutes
Cohort F, CDP6038 0.3 mg/kg, sc
CDP6038
100 mg/mL solution for injection Single sc injection
Cohort H, CDP6038 1.0 mg/kg, sc
CDP6038
100 mg/mL solution for injection Single sc injection
Cohort J, CDP6038 3.0 mg/kg, sc
CDP6038
100 mg/mL solution for injection Single sc injection
Cohort F, H, J, Placebo, sc
Placebo
0.9% sodium chloride for injection Single sc injection
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
MALE
Yes
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Berlin, , Germany
Countries
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Other Identifiers
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RA0001
Identifier Type: -
Identifier Source: org_study_id
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