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Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease

RecruitingPhase 1Ages 18 Years - anyAllEthyreal Bio, Inc.
NCT07885605 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • ETHY-001
  • Placebo
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Where

3 sites
Site 105
Orland Park, United States
Site 101
Las Vegas, United States
Site 113
Wilmington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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