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Safety and Tolerability of ETHY-001 Compared with Saline 0.9% in Adults with Thyroid Eye Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Thyroid Eye Disease is a condition where the tissues around the eyes become inflamed and swollen because of thyroid problems, often leading to bulging eyes, discomfort, and vision changes. The study tests an experimental medicine called ETHY-001, which is given as a small injection under the skin (subcutaneous) and is compared with a simple saline solution (placebo) that does not contain active drug.

The main goal of the trial is to learn whether ETHY-001 is safe and how well participants can tolerate it. Volunteers receive a single dose of the study drug or the saline solution and are then observed for a short period, during which they have regular check‑ups and blood tests to see how the body handles the medication (pharmacokinetics) and what effect it has on the body (pharmacodynamics). The study also looks at changes in standard thyroid blood tests to monitor any impact on thyroid function.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessments

    After joining the study, you will undergo initial medical examinations to record your health status. This includes checking vital signs, reviewing medical history, and performing baseline blood tests that measure thyroid function.

    These assessments establish the starting point for evaluating any changes that may occur during the trial.

  2. Step 2

    Randomization to Study Medication

    You will be randomly assigned to receive either the test medication ETHY-001 or a placebo (saline 0.9%). Randomization ensures that the comparison between the two groups is unbiased.

  3. Step 3

    Administration of Single Dose

    On the first study day, a single dose of the assigned product will be given by subcutaneous injection (injection under the skin).

    If you are in the test group, the dose is 300 mg of ETHY-001 in a solution for injection. If you are in the placebo group, an equivalent volume of saline 0.9% will be injected.

  4. Step 4

    Immediate Post‑Injection Observation

    After the injection, you will remain in the clinic for a short observation period. Staff will monitor you for any immediate adverse events (unwanted effects) such as reactions at the injection site or changes in vital signs.

    This observation helps ensure your safety before you leave the facility.

  5. Step 5

    Scheduled Follow‑Up Visits for Safety and Blood Sampling

    You will return to the clinic for several follow‑up visits that are planned by the study protocol. During each visit, the following will be performed:

    Safety monitoring: assessment of any new or ongoing adverse events, physical examination, and vital sign measurement.

    Blood sampling: collection of blood to determine pharmacokinetics (how your body absorbs, distributes, metabolizes, and eliminates ETHY-001) and to repeat thyroid function tests.

    The exact timing of these visits (for example, on days after the dose) will be provided to you by the study team.

  6. Step 6

    Final Study Visit and Conclusion

    At the last scheduled visit, a comprehensive safety evaluation will be performed, and final blood samples will be taken to complete the pharmacokinetic and thyroid assessments.

    You will receive a summary of the study procedures you completed. After this visit, your participation in the trial is concluded.

Who can join the trial?

5 criteria

  • Be between 18 and 65 years old and identify as male or female when you sign the study paperwork.
  • Have a body mass index (BMI) between 18 and 32 kg/m² (or at least 18 kg/m² for certain parts of the study). BMI is a simple number that compares your weight to your height.
  • Agree to follow all the study’s rules and procedures.
  • Be able to give written informed consent, which means you understand the study and can sign a paper confirming your agreement.
  • Agree to take the specific medicines and follow the monitoring plan that the clinic will provide.

Who cannot join the trial?

20 criteria

  • People who could become pregnant (anyone assigned female at birth who is not postmenopausal or not surgically sterilized) must agree to use birth control and must not donate sperm or eggs; if they do not agree, they cannot join the study.
  • Women who are currently breastfeeding are excluded, unless the baby does not receive any breast milk while the birth‑control rules are in effect.
  • Anyone with a serious heart problem (such as stroke, heart attack, unstable chest pain, heart surgery, or heart failure), major depression, uncontrolled high cholesterol, low sodium, low blood sugar, or a very slow heart rate is not allowed to participate.
  • People who have had any type of cancer (malignant condition) in the past 12 months, except for successfully treated skin cancer, cannot take part.
  • If a person has a significant illness within the 7 days before the study drug is given, they are excluded.
  • Any other medical condition that the doctor believes would make it hard to follow the study plan or could be unsafe, including hearing problems related to Thyroid Eye Disease, is a reason to be excluded.
  • People who have multiple drug allergies or are allergic to any ingredient in the study medication are excluded.
  • People who cannot tolerate a subcutaneous (under the skin) injection, have an active skin rash, or have large abdominal scars that could interfere with the injection are excluded.
  • People whose blood pressure is high (systolic >150 mmHg or diastolic >95 mmHg) after resting for 10 minutes are excluded.
  • People whose heart test (12‑lead ECG) shows serious abnormalities or whose QT interval (a measure of heart rhythm) is longer than 450 ms for men or 470 ms for women are excluded.
  • People who have abused alcohol or drugs (including prescription, illegal, or recreational) in the past 12 months or are considered at high risk of starting again are excluded.
  • People who have taken an investigational (experimental) drug within the last 60 days, or are still being followed up from another clinical study, cannot join.
  • People who have used any prescription or over‑the‑counter medicines (except acetaminophen up to 1000 mg/day), antacids, vitamins (beyond a normal multivitamin with limited selenium and biotin), herbal or dietary supplements (including St John’s Wort) within 14 days (or five drug half‑lives, whichever is longer) before the first dose, unless the doctor decides the medicines will not affect the study, are excluded.
  • People whose liver blood tests show ALT or AST more than twice the normal limit, or whose total bilirubin (a liver function marker) is more than 1.5 times normal (unless due to mild Gilbert’s syndrome and still under 2 times normal) are excluded.
  • People whose kidney function, measured as estimated glomerular filtration rate, is 45 mL/min/1.73 m² or lower are excluded.
  • People who test positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibodies at screening are excluded.
  • People who test positive for alcohol or drugs of abuse at screening or just before the first dose are excluded.
  • People who have done very intense exercise or contact sports within 24 hours before taking the study drug are excluded.
  • People who have donated more than 450 mL of blood or blood products in the past 30 days are excluded.
  • People who have previously been treated with teprotumumab or other drugs that block the insulin‑like growth factor‑1 receptor are excluded.
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Investigated drugs

ETHY-001 is an experimental medication being studied to see if it is safe and well‑tolerated in people. In the trial it is given as a liquid that is injected just under the skin. Participants receive a single dose that is gradually increased in later groups to understand how the drug is absorbed, distributed, and eliminated from the body (pharmacokinetics) and what biological effects it produces (pharmacodynamics). The main purpose of the study is to gather information about any side effects and overall safety, which will help decide whether the drug can move on to later stages of testing.

What is already known about the treatment

  • Saline 0.9%

    This is a sterile salt‑water solution that is given by subcutaneous injection as a placebo in the study. It is a well‑known medical product that has been used for many years for fluid replacement and as a control in clinical trials. The solution does not treat thyroid eye disease and works only as an inactive filler. It is classified as an isotonic electrolyte solution.

  • ETHY-001

    ETHY-001 is administered as a 300 mg subcutaneous injection of a clear solution for injection. It is an experimental drug that is currently being studied in early‑stage clinical trials and has not yet been approved for regular medical use. The drug is being tested for thyroid eye disease, where it aims to reduce eye swelling and inflammation. It works by modulating immune pathways that cause inflammation, and it belongs to the class of immunomodulatory agents.

Investigated diseases

Thyroid Eye Disease - Thyroid Eye Disease is an autoimmune condition that affects the tissues around the eyes, most commonly in people with thyroid disorders. It causes inflammation and swelling of the eye muscles and orbital fat, leading to bulging of the eyes, eye‑movement problems, and dryness. Over time, the swelling may stabilize or progress to fibrosis, which can further restrict eye movement and alter appearance.
Trial detailsLast updated 23 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-526257-33-00Protocol codeETHY-001-01-01Estimated enrolment21 patients

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