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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00867100 |
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).
Condition | Intervention | Phase |
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Psoriasis |
Drug: AMG 827 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 81 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Part A:
Part B:
Exclusion Criteria:
Part A:
Part B:
Contact: Amgen Call Center | 866-572-6436 |
Australia | |
Research Site | Recruiting |
Melbourne, Australia | |
Australia, South Australia | |
Research Site | Recruiting |
Adelaide, South Australia, Australia | |
Canada, Ontario | |
Research Site | Recruiting |
Waterloo, Ontario, Canada |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060279 |
Study First Received: | March 20, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00867100 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; United States: Food and Drug Administration |
Skin Diseases Psoriasis Healthy Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |