🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT06401044
Active, not recruiting Phase 1/2

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

NCT06401044 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Phase 1/2
Started
2024-05-30
Last updated
2026-08-10

Condition(s) studied

Thyroid Eye Disease

Investigational drug(s) / intervention(s)

AMG 732 →Placebo

AMG 732: SC injection

Placebo: SC injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Applied Research Center of Arkansas Little Rock Arkansas
Amy Patel Jain MD Newport Beach California
Levenson Eye Associates Jacksonville Florida
Ilumina Medical Research Kissimmee Florida
Sarasota Retina Institute Sarasota Florida
Vision Medical Research, Inc. Orland Park Illinois
Massachusetts Eye and Ear Infirmary Boston Massachusetts
Ppd Las Vegas Research Unit Las Vegas Nevada
Erie Retina Research Erie Pennsylvania
Baylor College of Medicine Medical Center Houston Texas
Consano Clinical Research, LLC Shavano Park Texas
West Virginia University Morgantown West Virginia
Macquarie University North Ryde New South Wales
North Shore Private Hospital St Leonards New South Wales
Vancouver General Hospital Vancouver British Columbia
Santé Québec Est-de-l'Île-de-Montréal - Universitaire Montreal Quebec
CHU de Québec-Université Laval - CUO-Recherche Clinique, Hopital du Saint-Sacrement Québec Quebec
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec Nantes France
Hopital Pitie-Salpetriere Paris France
Universitaetsklinikum Essen Essen Germany
Buergerhospital und Clementine Kinderhospital gGmbH Frankfurt am Main Germany
Universitaetsklinikum Freiburg Freiburg im Breisgau Germany
Universitaetsklinikum Leipzig AoeR Leipzig Germany
General Hospital of Athens Laiko Athens Greece
Ippokratio General Hospital of Thessaloniki Thessaloniki Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Socio Sanitaria Territoriale dei Sette Laghi Varese Italy
Aichi Medical University Hospital Nagakute-shi Aichi-ken
Hayashi Eye Hospital Fukuoka Fukuoka
Kozawa Eye Hospital And Diabetes Center Mito Ibaraki
University of Miyazaki Hospital Miyazaki Miyazaki
Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Gdansk Poland
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo Poznan Poland
Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa Swidnica Poland
Eb Group Spolka z ograniczona odpowiedzialnoscia Warsaw Poland
National University Hospital Singapore Singapore
Singapore National Eye Centre Singapore Singapore
Hospital Universitario Virgen Macarena Seville Andalusia

+ 4 more sites — see the full list on the official registry below.

More Amgen trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06401044 on ClinicalTrials.gov ↗ ← All trials in Germany