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A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
Sponsor: Amgen
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
Conditions
Interventions
AMG 732
SC injection
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