Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
NCT ID: NCT00867100
Last Updated: 2019-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2007-12-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo treatment
Placebo
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
140 mg SC
140 mg SC PsO
140 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
350 mg SC
350 mg SC PsO
350 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
700 mg IV
700 mg IV PsO
700 mg IV
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Interventions
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700 mg IV
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
350 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Placebo
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
140 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
* Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
Part B:
* 18 - 55 years old inclusive at Screening
* Active but clinically stable, plaque psoriasis
* Psoriasis involving ≥ 10% of the body surface area
* A minimum PASI score of ≥ 10 obtained during the screening period
Exclusion Criteria
* History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c \> 7%, history of splenectomy)
Part B:
* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
18 Years
55 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060279
Identifier Type: -
Identifier Source: org_study_id
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