Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis

NCT00757042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-09-21

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Summary

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.

Conditions

Interventions

DRUG

Tezepelumab

Administered by subcutaneous or intravenous injection

DRUG

Placebo

Matching placebo administered by subcutaneous or intravenous injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-18
Primary Completion
2011-01-05
Completion
2011-01-05

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00757042 on ClinicalTrials.gov