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Clinical Trials in the USA / NCT07885605
Recruiting Phase 1

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

NCT07885605 · tracked via the Priya Life Science USA tracker
Sponsor
Ethyreal Bio, Inc
Phase
Phase 1
Started
2026-07-06
Last updated
2026-10-26

Condition(s) studied

Thyroid Eye Disease (TED)Graves' DiseaseEye Diseases, HereditaryEye DiseasesExophthalmosOrbital DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesGraves OphthalmopathyProptosis

Investigational drug(s) / intervention(s)

ETHY-001Placebo

ETHY-001: ETHY-001

Placebo: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Overall safety profile as assessed by type, frequency, severity and causality of adverse events — Day 1 through End of Study (up to 84 weeks)

Trial sites (3)

FacilityCityRegionStatus
Site 105 Orland Park Illinois Recruiting
Site 101 Las Vegas Nevada Active Not Recruiting
Site 113 Wilmington North Carolina Recruiting

Other trials for the same condition

Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies Enrolling by invitation
Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study Active, not recruiting
A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease Enrolling by invitation
Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07885605 on ClinicalTrials.gov ↗ ← All trials in the USA