ETHY-001 safety and activity in Thyroid Eye Disease (TED)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial evaluates a monoclonal antibody, ETHY-001, in healthy volunteers and participants with Thyroid Eye Disease. It looks at safety, tolerability, how the body processes the drug, and the drug’s biological effects after a single subcutaneous dose. The study includes Part A (healthy volunteers) and Part B (moderate-to-severe TED patients), with live monitoring and predefined safety criteria. Participants must meet specific health criteria, avoidance of prior related therapies, and consent to protocol procedures across multiple U.S. sites. The trial uses ETHY-001 and placebo to determine initial safety signals and potential clinical activity in TED.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site 105
  Orland Park, Illinois, United States Recruiting
• Site 113
  Wilmington, North Carolina, United States Recruiting
• Site 101
  Las Vegas, Nevada, United States Active not recruiting

Study contacts

• Study coordinator: Ethyreal Bio
• Email: medinfo@ethyrealbio.com
• Phone: 617-300-2108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.