Study Complete
Sponsor ID
20070620
Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults with Atopic Dermatitis
Study Details
This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.
Protocol Summary
Primary Outcome Measures
Safety evaluations: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations, laboratory safety tests, ECGs, and the development of anti-AMG 157 antibodies
Timeframe: Part A - 85 days; Part B - 113 days
Secondary Outcome Measures
Eczema Area & Severity Index (EASI) score and Investigator’s Global Assessment (IGA) score
Timeframe: Part B only - 113 days
Serum PK parameters
Timeframe: Part A - 85 days; Part B - 113 days
Study Documents
Study Synopsis
Available Language(s): English
Locations
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