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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00757042 |
This study is a phase 1 single dose escalation study of AMG 157 in healthy subjects and subjects with moderate to severe atopic dermatitis. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of AMG 157.
Condition | Intervention | Phase |
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Atopic Dermatitis Healthy Volunteers |
Drug: AMG 157 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis |
Estimated Enrollment: | 88 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 157: Active Comparator
Six subjects in each cohort (cohort 1 to 8) will receive AMG 157 in Part A 18 subjects in cohorts 9 and 10 (Part B) will receive AMG 157
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Drug: AMG 157
Part A (healthy subjects): 6 subcutaneous (SC) cohorts and 2 intravenous (IV) cohorts receiving a single dose of either AMG 157 (dose escalating by cohort) or placebo. Part B (subjects with moderate to severe atopic dermatitis):two cohorts receiving a single dose (SC or IV; dose to be determined) of AMG 157 or placebo.
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placebo: Placebo Comparator
2 subjects of each cohort (cohort 1 to 8) will receive placebo in Part A 6 subjects in cohorts 9 and 10 (Part B) will receive placebo
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Drug: AMG 157
Part A (healthy subjects): 6 subcutaneous (SC) cohorts and 2 intravenous (IV) cohorts receiving a single dose of either AMG 157 (dose escalating by cohort) or placebo. Part B (subjects with moderate to severe atopic dermatitis):two cohorts receiving a single dose (SC or IV; dose to be determined) of AMG 157 or placebo.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20070620 |
Study First Received: | September 18, 2008 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00757042 History of Changes |
Health Authority: | United States: Food and Drug Administration |
atopic dermatitis skin diseases healthy volunteer |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Healthy Skin Diseases, Genetic Dermatitis |
Hypersensitivity Dermatitis, Atopic Immune System Diseases Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |