Actively Recruiting
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Adults and Adults With Moderate-to-Severe Active Thyroid Eye Disease
Led by Amgen · Updated on 2026-05-15
88
Participants Needed
34
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of AMG 732 in both healthy individuals and people with moderate-to-severe active Thyroid Eye Disease (TED). The study is divided into two parts: Part A focuses on single subcutaneous doses to assess safety, while Part B investigates multiple doses to evaluate efficacy in improving eye symptoms related to TED. This study includes participants aged 18 to 65 years and is sponsored by Amgen. Participants in Part A receive single ascending doses of AMG 732 or placebo through subcutaneous injections in six different groups. Part B participants receive either low, medium, or high doses of AMG 732 or placebo, also by subcutaneous injection, over approximately six months. The study involves randomized assignment to treatment groups and uses a double-masked design to ensure unbiased results. Throughout the study, participants undergo various assessments including monitoring of adverse events, blood tests to measure AMG 732 levels and antibodies, eye examinations measuring proptosis, and quality of life questionnaires related to visual function and appearance. Safety and treatment effects are followed for up to 36 weeks in Part A and up to 48 weeks in Part B. The total duration and detailed evaluations aim to provide comprehensive data on AMG 732’s impact on TED and healthy subjects.
CONDITIONS
Brief 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...
- Male or female aged 18 to 55 years for Part A (Phase 1) and aged 18 to 65 years for Part B (Phase 2)
- Female participants in Part A must be of non-childbearing potential
- Body mass index (BMI) between 18 and 30 kg/m² at screening
- Ability to provide informed consent
- Considered in good general health based on medical history, lab tests, vital signs, ECG, and physical exam
- Healthy Japanese participants in Part A cohort 4 must meet specific ethnicity and residency criteria
- For Part B: diagnosed with moderate-to-severe active Thyroid Eye Disease with onset within 15 months prior to baseline
- Clinical Activity Score (CAS) ≥3 in the most affected eye at screening and baseline
- Proptosis ≥18mm in the study eye at baseline
- Baseline subjective binocular diplopia score greater than 0
- Does not require immediate surgical eye intervention and is not planning corrective surgery or irradiation during the trial
You will not qualify if you...
- Malignant condition within the past 12 months or major surgery within 8 weeks before screening or planned elective surgery during the 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 (IV, oral, eye drops) within 3 weeks prior to first dose, except for topical/inhaled steroids or short-course asthma steroids
- Known hypersensitivity to teprotumumab or other monoclonal antibodies
- History of substance abuse within 12 months before screening
- Recent blood donation, significant blood loss, transfusion within 60 days or plasma donation within 7 days prior to dosing
- For Part A: blood pressure or ECG abnormalities at screening
- For Part B: use of steroids or immunosuppressive agents within 3 months prior to first injection
- Prior use of teprotumumab or IGF-1R inhibitors
- Prior orbital irradiation or decompression in the study eye
- History or existing inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive single ascending doses of AMG 732 or placebo by subcutaneous injection in multiple cohorts to evaluate safety and efficacy.
Multiple visits for dosing and assessments over 6 months
Duration - Up to 36 to 48 weeks depending on study part
Participants are monitored for safety and treatment effects after dosing ends.
Regular visits for safety and pharmacokinetic assessments
Trial Site Locations
Total: 34 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
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece, 54642
Actively Recruiting
17
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
18
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
19
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
20
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan, 480-1195
Actively Recruiting
21
Hayashi Eye Hospital
Fukuoka, Fukuoka, Japan, 812-0011
Actively Recruiting
22
Kozawa Eye Hospital And Diabetes Center
Mito, Ibaraki, Japan, 310-0845
Actively Recruiting
23
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan, 889-1692
Actively Recruiting
24
Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia
Gdansk, Poland, 80-180
Actively Recruiting
25
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo
Poznan, Poland, 60-354
Actively Recruiting
26
Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Swidnica, Poland, 58-100
Actively Recruiting
27
Eb Group Spolka z ograniczona odpowiedzialnoscia
Warsaw, Poland, 00-189
Actively Recruiting
28
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
29
Singapore National Eye Centre
Singapore, Singapore, 169608
Actively Recruiting
30
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
31
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
32
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
33
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
34
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
A
Amgen Call Center
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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