Thyroid Eye Disease study: ETHY-001
Official title Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07885605
What this study is testing
What is ETHY-001?
ETHY-001 is an investigational once‑subcutaneous injectable medicine being studied for Thyroid Eye Disease (TED).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and well-tolerated ETHY-001 is, and to learn how it moves and works in the body.
- Who it's for
- Healthy adults and adults with thyroid eye disease.
- What's involved
- Participants receive one subcutaneous (under the skin) injection of ETHY-001 and are monitored for safety and drug levels.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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 will apply.
You likely can't join if
- 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.
See the full eligibility criteria
- 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 will apply. Part B Only: \- Must meet the criteria for moderate-to-severe TED.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Orland Park, Illinois, United States
- Wilmington, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orland Park, Illinois, United States; Wilmington, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.