CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01405963
NCT01405963Phase 1Completed

Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma

Amgen·interventional·Posted Jul 29, 2011·Updated Oct 17, 2022

In Brief

A Phase 1 clinical trial evaluating Placebo and Tezepelumab for Asthma. Completed, enrolled 31 participants across 5 sites.

Detailed Summary

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartOct 31, 2011
Primary CompletionApr 5, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.9 years ago

Interventions

Placebodrug

Administered in a 1-hour intravenous infusion

Tezepelumabbiological

Administered in a 1-hour intravenous infusion