Back to Trials
NCT06401044PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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

Amgen

Start Date

5/30/2024

Completion Date

8/13/2027

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.

Detailed Description

Recruitment has ended for the Phase 1 portion of the study and will reopen when Phase 2 begins recruitment.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion criteria for Part A/Phase 1 only: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Male or female aged 18 to 55 years (Part A). * Female participants must be of non-childbearing potential. * Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, at screening. * The participant has adequate venous access and can receive intravenous (IV) therapy. * The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening. * Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan. Inclusion criteria for Part B/Phase 2 only: * Male or female aged 18 to 65 years. * Moderate-to-severe active TED. * The participant had onset of active TED within 15 months prior to baseline. * Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline. * Proptosis ≥18mm in the study eye at baseline. * Participants with baseline subjective binocular diplopia score \>0. * Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial. Exclusion criteria for Part A and Part B: * Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study. * Active liver or kidney disfunction at screening. * Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening. * Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening. * Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control. * Known hypersensitivity to teprotumumab or any other monoclonal antibody products. * History of substance abuse within 12 months before screening. * Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing. Exclusion criteria for PartA/Phase 1 only • Blood pressure or ECG abnormalities at screening. Exclusion criteria for Part B/Phase 2 only: * Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug. * Use of teprotumumab or any other IGF-1R inhibitor. * Prior orbital irradiation or decompression in the study eye. * History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease). Other protocol-defined inclusion/exclusion criteria apply.

Interventions

DRUG

AMG 732

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Thyroid Eye Disease

Locations

Applied Research Center of Arkansas

Little Rock, Arkansas 72205

United States

Amy Patel Jain MD

Newport Beach, California 92660

United States

Levenson Eye Associates

Jacksonville, Florida 32204

United States

Ilumina Medical Research

Kissimmee, Florida 34744

United States

Sarasota Retina Institute

Sarasota, Florida 34239

United States

Vision Medical Research, Inc.

Orland Park, Illinois 60462

United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts 02114

United States

Ppd Las Vegas Research Unit

Las Vegas, Nevada 89113

United States

Erie Retina Research

Erie, Pennsylvania 16505

United States

Baylor College of Medicine Medical Center

Houston, Texas 77030

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Macquarie University

North Ryde, New South Wales 2109

Australia

North Shore Private Hospital

St Leonards, New South Wales 2065

Australia

Vancouver General Hospital

Vancouver, British Columbia V5Z 0A6

Canada

Santé Québec Est-de-l'Île-de-Montréal - Universitaire

Montreal, Quebec H1T 2M4

Canada

CHU de Québec-Université Laval - CUO-Recherche Clinique, Hopital du Saint-Sacrement

Québec, Quebec G1S 4L8

Canada

Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

Nantes, 44800

France

Hopital Pitie-Salpetriere

Paris, 75013

France

Universitaetsklinikum Essen

Essen, 45147

Germany

Buergerhospital und Clementine Kinderhospital gGmbH

Frankfurt am Main, 60318

Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, 04013

Germany

General Hospital of Athens Laiko

Athens, 11527

Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, 54642

Greece

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

Azienda Socio Sanitaria Territoriale dei Sette Laghi

Varese, 21100

Italy

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken 480-1195

Japan

Hayashi Eye Hospital

Fukuoka, Fukuoka 812-0011

Japan

Kozawa Eye Hospital And Diabetes Center

Mito, Ibaraki 310-0845

Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki 889-1692

Japan

Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

Gdansk, 80-180

Poland

Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo

Poznan, 60-354

Poland

Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

Swidnica, 58-100

Poland

Eb Group Spolka z ograniczona odpowiedzialnoscia

Warsaw, 00-189

Poland

National University Hospital

Singapore, 119074

Singapore

Singapore National Eye Centre

Singapore, 169608

Singapore

Hospital Universitario Virgen Macarena

Seville, Andalusia 41009

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan