Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01093911
First received: March 12, 2010
Last updated: January 3, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
| Condition | Intervention | Phase |
|---|---|---|
|
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease |
Biological: CDP7657 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
- Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
- Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
- Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | March 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CDP7657
CDP7657 in dose escalating cohorts
|
Biological: CDP7657
Ascending single doses of CDP7657
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo: 0.9% sodium chloride aqueous solution
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093911
Locations
| Belgium | |
| 6 | |
| Leuven, Belgium | |
| Bulgaria | |
| 9 | |
| Sofia, Bulgaria | |
| Germany | |
| 1 | |
| Berlin, Germany | |
| 2 | |
| Erlangen, Germany | |
| 3 | |
| Frankfurt, Germany | |
| 4 | |
| Hannover, Germany | |
| 8 | |
| Kiel, Germany | |
| 7 | |
| Münster, 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: | NCT01093911 History of Changes |
| Other Study ID Numbers: | SL0013, 2009-013617-10 |
| Study First Received: | March 12, 2010 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by UCB, Inc.:
|
Lupus SLE |
Additional relevant MeSH terms:
|
Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic |
ClinicalTrials.gov processed this record on May 16, 2013