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RecruitingAccepts healthy volunteersPhase 1

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

Ethyreal Bio, Inc. · NCT07885605

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
72
US sites recruiting
2
Study start
July 6, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ETHY-001; Placebo

Conditions: Thyroid Eye Disease (TED); Graves' Disease; Eye Diseases, Hereditary; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Graves Ophthalmopathy; Proptosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Ethyreal Bio · 617-300-2108 · medinfo@ethyrealbio.com
  • Ethyreal Bio · Patientadvocacy@ethyrealbio.com
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