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RECRUITING
NCT06401044
PHASE1/PHASE2

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Official title: A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2024-05-30

Completion Date

2027-08-13

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

DRUG

AMG 732

SC injection

OTHER

Placebo

SC injection

Locations (30)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Ilumina Medical Research

Kissimmee, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Vision Medical Research, Inc.

Orland Park, Illinois, United States

Ppd Las Vegas Research Unit

Las Vegas, Nevada, United States

Erie Retina Research

Erie, Pennsylvania, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

West Virginia University

Morgantown, West Virginia, United States

Macquarie University

North Ryde, New South Wales, Australia

North Shore Private Hospital

St Leonards, New South Wales, Australia

Vancouver General Hospital

Vancouver, British Columbia, Canada

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Nantes, France

Hopital Pitie-Salpetriere

Paris, France

Universitaetsklinikum Essen

Essen, Germany

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, Japan

Hayashi Eye Hospital

Fukuoka, Fukuoka, Japan

Kozawa Eye Hospital And Diabetes Center

Mito, Ibaraki, Japan

Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

Gdansk, Poland

Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

Swidnica, Poland

Eb Group Spolka z ograniczona odpowiedzialnoscia

Warsaw, Poland

Singapore National Eye Centre

Singapore, Singapore

Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan