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Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
RecruitingPhase 1Healthy volunteers welcome
A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility 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.
About the study
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.
What is being tested
- ETHY-001 (drug)
- Placebo (other)
Sponsor: Ethyreal Bio, Inc. · Participants: 72 · Started: Jul 6, 2026
Contact the study team
- Ethyreal Bio · Phone: 617-300-2108
Official record on ClinicalTrials.gov — NCT07885605
Locations in the U.S.
| Illinois | Site 105, Orland Park |
| North Carolina | Site 113, Wilmington |
Conditions
- Graves Ophthalmopathy
- Graves Disease
- Eye Care
- Thyroid Diseases
- Endocrine Diseases
- Hyperthyroidism
- Autoimmune Diseases
- Immune System and Disorders
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.