A Phase 1 interventional study of ETHY-001 and Placebo in Thyroid Eye Disease (TED), Graves' Disease and Eye Diseases, Hereditary, sponsored by Ethyreal Bio, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ethyreal Bio, Inc. · Phase 1, Interventional, and Treatment
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.
198 studies on the registry are indexed under Graves Ophthalmopathy; 60 are open to participants now.
This study's planned enrollment of 72 is above the median of 64 across 147 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →This is the only study on the registry with Ethyreal Bio, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parts A and B:
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:
Other protocol-defined exclusion criteria apply.
Participants in multiple cohorts will receive ETHY-001 in Single Ascending Doses (SAD).
Drug: ETHY-001
Participants in multiple cohorts will receive a placebo comparator.
Other: Placebo
ETHY-001
Placebo
Overall safety profile as assessed by type, frequency, severity and causality of adverse events
Time frame: Day 1 through End of Study (up to 84 weeks)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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