Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01093911 |
Date of registration:
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12/03/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients. |
Date of first enrolment:
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March 2010 |
Target sample size:
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44 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01093911 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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Phase:
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Phase 1
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Countries of recruitment
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Belgium
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Bulgaria
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Germany
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Contacts
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Name:
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UCB Clinical Trial Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy Volunteers and subjects with SLE
Exclusion Criteria:
- Severe neuropsychiatric or severe renal SLE
- History of chronic, recurrent, or recent severe infection
- Significant hematologic abnormalities
- History of cancer, heart failure, renal disease, liver disease or other serious
illness
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Skin and Connective Tissue Diseases
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Autoimmune Diseases
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Connective Tissue Disease
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Immune System Diseases
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Intervention(s)
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Biological: CDP7657
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Other: Placebo
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Primary Outcome(s)
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Assessment of safety of CDP7657 as per Adverse Event (AE) reporting
[Time Frame: Day 0 to 119]
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Secondary Outcome(s)
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Terminal elimination half-life (t 1/2)
[Time Frame: Day 0 to 119]
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Maximum plasma concentration (Cmax)
[Time Frame: Day 0 to 119]
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Time corresponding to Cmax (Tmax)
[Time Frame: Day 0 to 119]
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Plasma levels of anti-CDP7657 antibodies
[Time Frame: Day 0 to 119]
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Secondary ID(s)
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2009-013617-10
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SL0013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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