Recruiting
Phase 1

ETHY-001

Sponsor:

Ethyreal Bio, Inc.

Code:

NCT07885605

Conditions

Thyroid Eye Disease (TED)

Graves' Disease

Eye Diseases, Hereditary

Eye Diseases

Exophthalmos

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ETHY-001

Placebo

Study Details

Brief 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.

Conditions

Thyroid Eye Disease (TED)

Graves' Disease

Eye Diseases, Hereditary

Eye Diseases

Exophthalmos

Study ID

NCT07885605

Start date

Jul 6, 2026

Status verified date

Aug, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ETHY-001

Participants in multiple cohorts will receive ETHY-001 in Single Ascending Doses (SAD).

placebo comparator: Placebo

Participants in multiple cohorts will receive a placebo comparator.

Interventions

ETHY-001

ETHY-001

Placebo

Placebo

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Ethyreal Bio

617-300-2108medinfo@ethyrealbio.com

Ethyreal Bio

Patientadvocacy@ethyrealbio.com

Locations

Site 101

Recruiting

Las Vegas, Nevada, United States, 89113

More Information

Sponsor

Ethyreal Bio, Inc.

Last update posted

Oct 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Ethyreal Bio, Inc. on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.