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A randomized, Double-Masked, Placebo-Controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ETHY-001

NCT ID NCT07885605

Sponsor: Ethyreal Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease disease of orbital part of eye adnexa endocrine exophthalmos endocrine system disorder exophthalmos Eye Diseases, Hereditary eye disorder goiter Graves disease Graves Ophthalmopathy hyperthyroidism immune system disorder thyroid gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases Endocrine system diseases Exophthalmos Eye diseases Eye diseases, hereditary Goiter Graves ophthalmopathy Graves' disease Hyperthyroidism Immune system diseases Orbital diseases Proptosis Thyroid diseases Thyroid eye disease (TED)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Site 101

    RECRUITING

    Las Vegas, Nevada, 89113, United States

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