A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
NCT ID: NCT06401044
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
88 participants
INTERVENTIONAL
2024-05-30
2027-08-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part A: AMG 732
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
AMG 732
SC injection
Part A: Placebo
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Placebo
SC injection
Part B: AMG 732 Low Dose
Participants will receive AMG 732 low dose SC.
AMG 732
SC injection
Part B: AMG 732 Medium Dose
Participants will receive AMG 732 medium dose SC.
AMG 732
SC injection
Part B: AMG 732 High Dose
Participants will receive AMG 732 high dose SC.
AMG 732
SC injection
Part B: Placebo
Participants will receive placebo SC.
Placebo
SC injection
Interventions
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AMG 732
SC injection
Placebo
SC injection
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
• Blood pressure or ECG abnormalities at screening.
* 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).
18 Years
65 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
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
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230302
Identifier Type: -
Identifier Source: org_study_id