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A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 May 2022

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At a glance

  • Drugs Tezepelumab (Primary) ; Tezepelumab (Primary)
  • Indications Asthma; Atopic dermatitis
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Amgen

    • Most Recent Events

    • 28 Dec 2020 Data from 7 studies (NCT00757042, NCT00972179, NCT01405963, NCT01913028, NCT02512900, NCT02525094 & NCT02054130) was used to develop a population PK model to guide tezepelumab dose selection for phase III trials in patients with severe asthma, published in the Journal of Clinical Pharmacology.
    • 19 Feb 2019 Results assessing safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses in two randomized, double-blind, placebo-controlled Phase 1 studies (NCT00757042 and NCT00972179) published in the Clinical Pharmacology and Therapeutics
    • 08 Aug 2014 New trial record

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