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

NCT07885605 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ETHY-001-01-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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; Orbital Diseases; Goiter; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Graves Ophthalmopathy; Proptosis; Thyroid Diseases; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• Overall safety profile as assessed by type, frequency, severity and causality of adverse events

  Day 1 through End of Study (up to 84 weeks)

Study Arms (2)

ETHY-001

EXPERIMENTAL

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

Drug: ETHY-001

Placebo

PLACEBO COMPARATOR

Participants in multiple cohorts will receive a placebo comparator.

Other: Placebo

Interventions

Placebo OTHER

Placebo

Placebo

ETHY-001 DRUG

ETHY-001

ETHY-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Part B Only:
• \- Must meet the criteria for moderate-to-severe TED.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethyreal Bio, Inc.: lead

Study Sites (1)

Site 101

Las Vegas, Nevada, 89113, United States

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease; Eye Diseases, Hereditary; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ethyreal Bio

CONTACT

617-300-2108; medinfo@ethyrealbio.com

Ethyreal Bio

CONTACT

Patientadvocacy@ethyrealbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 21, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)