A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease
Amgen
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.
Description
Recruitment has ended for the Phase 1 portion of the study and will reopen when Phase 2 begins recruitment.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 measu…
Interventions
- DrugAMG 732
SC injection
- OtherPlacebo
SC injection
Locations (30)
- Applied Research Center of ArkansasLittle Rock, Arkansas
- Levenson Eye AssociatesJacksonville, Florida
- Ilumina Medical ResearchKissimmee, Florida
- Sarasota Retina InstituteSarasota, Florida
- Vision Medical Research, Inc.Orland Park, Illinois
- Ppd Las Vegas Research UnitLas Vegas, Nevada