Overview

The primary objective of study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ETHY-001 in healthy volunteers and participants with Thyroid Eye Disease after single subcutaneous doses.

Eligibility

Inclusion Criteria:

Parts A and B:

• Body mass index of 18 kg/m2 at screening.
• Agree to comply with all protocol requirements.
• Able to provide written informed consent.
• Agree to defined medications and monitoring as instructed by the site.

Other protocol-defined inclusion criteria will apply.

Part B Only:

\- Must meet the criteria for moderate-to-severe TED.

Exclusion Criteria:

Part A and Part B:

• Significant medical conditions or physical findings that may affect participant safety.
• Active liver or kidney dysfunction at screening.
• Known hypersensitivity to monoclonal antibody products and/or subcutaneous injections.
• Blood pressure or ECG abnormalities at screening.
• Pregnancy of plans for pregnancy; breastfeeding.
• The participant has a history of alcohol or substance abuse within the last 12 months before screening.
• Use of any investigational drug within 60 days prior to the first injection of study drug.
• History of treatment with teprotumumab or other anti-IGF-1R monoclonal antibodies.

Other protocol-defined exclusion criteria apply.