Actively Recruiting
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
Led by Amgen · Updated on 2026-04-09
88
Participants Needed
30
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before study activities
- Male or female aged 18 to 55 years (Part A)
- Female participants in Part A must be of non-childbearing potential
- Body mass index between 18 and 30 kg/m² at screening
- Adequate venous access for intravenous therapy
- Considered in good general health by investigator
- Healthy Japanese participants in cohort 4 meeting specific ethnic and residency criteria (Part A only)
- Male or female aged 18 to 65 years (Part B)
- Moderate-to-severe active Thyroid Eye Disease
- Onset of active TED within 15 months prior to baseline
- Clinical diagnosis of Graves' disease with Clinical Activity Score ≥3 in the most affected eye
- Proptosis ≥18mm in the study eye at baseline
- Baseline subjective binocular diplopia score greater than 0
- No immediate need for surgical ophthalmological intervention and no planned corrective surgery or irradiation during trial
You will not qualify if you...
- Malignant condition in past 12 months or major surgery within 8 weeks or planned elective surgery during study
- Active liver or kidney dysfunction at screening
- Positive hepatitis B, hepatitis C, or HIV test at screening
- Glycated hemoglobin (HbA1c) > 6.5% or fasting glucose >126 mg/dL at screening
- Use of any steroid within 3 weeks prior to first dose (except topical, inhaled, or short-course for asthma)
- Known hypersensitivity to teprotumumab or monoclonal antibodies
- History of substance abuse within 12 months prior to screening
- Blood donation, significant blood loss, transfusion within 60 days or plasma donation within 7 days prior to dosing
- Blood pressure or ECG abnormalities at screening (Part A only)
- Use of steroid or immunosuppressive agents or monoclonal antibodies within 3 months prior to first injection (Part B only)
- Prior orbital irradiation or decompression in the study eye (Part B only)
- History or existing inflammatory bowel disease such as ulcerative colitis or Crohn's disease (Part B only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Levenson Eye Associates
Jacksonville, Florida, United States, 32204
Actively Recruiting
3
Ilumina Medical Research
Kissimmee, Florida, United States, 34744
Actively Recruiting
4
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
5
Vision Medical Research, Inc.
Orland Park, Illinois, United States, 60462
Actively Recruiting
6
Ppd Las Vegas Research Unit
Las Vegas, Nevada, United States, 89113
Actively Recruiting
7
Erie Retina Research
Erie, Pennsylvania, United States, 16505
Actively Recruiting
8
Consano Clinical Research, LLC
Shavano Park, Texas, United States, 78231
Actively Recruiting
9
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
10
Macquarie University
North Ryde, New South Wales, Australia, 2109
Actively Recruiting
11
North Shore Private Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
12
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 0A6
Actively Recruiting
13
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Nantes, France, 44800
Actively Recruiting
14
Hopital Pitie-Salpetriere
Paris, France, 75013
Actively Recruiting
15
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
16
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
17
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
18
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
19
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan, 480-1195
Actively Recruiting
20
Hayashi Eye Hospital
Fukuoka, Fukuoka, Japan, 812-0011
Actively Recruiting
21
Kozawa Eye Hospital And Diabetes Center
Mito, Ibaraki, Japan, 310-0845
Actively Recruiting
22
Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia
Gdansk, Poland, 80-180
Actively Recruiting
23
Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Swidnica, Poland, 58-100
Actively Recruiting
24
Eb Group Spolka z ograniczona odpowiedzialnoscia
Warsaw, Poland, 00-189
Actively Recruiting
25
Singapore National Eye Centre
Singapore, Singapore, 169608
Actively Recruiting
26
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
27
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
28
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
29
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
30
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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