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 States88 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 range18 Years – 65 Years
SexALL
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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…
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)