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Recruiting Phase 1, Phase 2 NCT06401044

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Trial Parameters

Condition Thyroid Eye Disease
Sponsor Amgen
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 88
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-05-30
Completion 2027-02-22
Interventions
AMG 732Placebo

Brief 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.

Eligibility Criteria

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

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