A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease (NCT06401044) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
United States, Australia, Canada88 participantsStarted 2024-05-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Number of Participants With Treatment-emergent Adverse Events
Timeframe: Day 1 through Week 36 (End of Study)
2
Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye
Timeframe: Baseline to End of Treatment (EoT) (approximately 6 Months)