A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545 (CP145)
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ClinicalTrials.gov Identifier: NCT00472758 |
Recruitment Status
:
Completed
First Posted
: May 14, 2007
Last Update Posted
: November 17, 2011
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Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
Tracking Information | ||||
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First Submitted Date ICMJE | May 11, 2007 | |||
First Posted Date ICMJE | May 14, 2007 | |||
Last Update Posted Date | November 17, 2011 | |||
Study Start Date ICMJE | February 2007 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126. [ Time Frame: Through day 26 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00472758 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Secondary endpoints are the PK and IM of single-dose IV MEDI-545. [ Time Frame: determination not stated ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545 | |||
Official Title ICMJE | A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Chronic Plaque Psoriasis | |||
Brief Summary | -To evaluate the safety and tolerability of a multiple doses of this drug in adult patients. | |||
Detailed Description | -The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Plaque Psoriasis | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00472758 | |||
Other Study ID Numbers ICMJE | MI-CP145 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | MedImmune LLC | |||
Study Sponsor ICMJE | MedImmune LLC | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | MedImmune LLC | |||
Verification Date | November 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |