Thyroid Eye Disease (TED)Phase 1NCT07885605
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
A Phase 1 study testing ETHY-001 in people with Thyroid Eye Disease (TED) and Graves' Disease, run by Ethyreal Bio, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Eye Disease (TED), Graves' Disease, Eye Diseases, Hereditary
- What is being tested?
- ETHY-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jul 2026to 15 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethyreal Bio contact
United States3 sites, 2 recruiting
- Active, not recruiting
Site 101
Las Vegas, Nevada, 89113
- Recruiting
Site 105
Orland Park, Illinois, 60462
- Recruiting
Site 113
Wilmington, North Carolina, 28403
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001
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
- Being tested
- ETHY-001, Placebo
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Eye Diseases, Hereditary, Eye Diseases, Exophthalmos, Orbital Diseases, Goiter, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETHY-001Drug
ETHY-001
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ETHY-001 | Experimental | Participants in multiple cohorts will receive ETHY-001 in Single Ascending Doses (SAD). Receives: Drug: ETHY-001 |
| Placebo | Placebo comparator | Participants in multiple cohorts will receive a placebo comparator. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety profile as assessed by type, frequency, severity and causality of adverse events
Measured: Day 1 through End of Study (up to 84 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start6 Jul 2026
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease (TED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethyreal Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885605
- Sponsor's protocol ID
- ETHY-001-01-01
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETHY-001
- ClinicalTrials.gov ID
- NCT07885605
- Acronym / sponsor ID
- ETHY-001-01-01
- Conditions
- Thyroid Eye Disease (TED), Graves' Disease, Eye Diseases, Hereditary, Eye Diseases, Exophthalmos, Orbital Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ethyreal Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETHY-001 | Experimental | Drug: ETHY-001Participants in multiple cohorts will receive ETHY-001 in Single Ascending Doses (SAD). |
| Placebo | Placebo comparator | Other: PlaceboParticipants in multiple cohorts will receive a placebo comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETHY-001ETHY-001 | Drug | ETHY-001 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ethyreal Bio contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ETHY-001 in people with Thyroid Eye Disease (TED) and Graves' Disease, run by Ethyreal Bio, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ethyreal Bio (617-300-2108, medinfo@ethyrealbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.