Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00867100
First received: March 20, 2009
Last updated: August 19, 2010
Last verified: August 2010
Tracking Information | |||||
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First Received Date ICMJE | March 20, 2009 | ||||
Last Updated Date | August 19, 2010 | ||||
Start Date ICMJE | December 2007 | ||||
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety & tolerability: AE's, clinically significant changes in safety labs, PE, vital signs, and development of anti-AMG 827 antibodies [ Time Frame: 9-12 Weeks ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00867100 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Characterize the pharmacokinetics (PK) of AMG 827 following single dose SC or IV administration in healthy subjects and subjects with moderate to severe PsO. [ Time Frame: 9-12 Weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis | ||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis | ||||
Brief Summary | This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Psoriasis | ||||
Intervention ICMJE | Drug: AMG 827
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). |
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Study Arm (s) | Experimental: 1
Intervention: Drug: AMG 827 |
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Publications * | |||||
* 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 | ||||
Enrollment ICMJE | 84 | ||||
Completion Date | September 2009 | ||||
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Part A:
Part B:
Exclusion Criteria: Part A:
Part B:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867100 | ||||
Other Study ID Numbers ICMJE | 20060279 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study Sponsor ICMJE | Amgen | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Amgen | ||||
Verification Date | August 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |