Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New injection for Graves' disease enters first human tests

NCT ID NCT07286656

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of a new drug called GenSci098 in 24 adults with Graves' disease, a condition where the thyroid is overactive. The main goal is to check safety and side effects over about 5 months. Researchers will also measure how the drug moves through the body. This is a first step to see if GenSci098 might help control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GenSci098
What this could lead to
If safe and effective, GenSci098 could offer a new treatment option for Graves' disease, potentially reducing the need for long-term medication.
What could go wrong
This is a very early Phase 1 trial with only 24 people, focused on safety. It is too soon to know if it works, and side effects are unknown.

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 24 people

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

Started

Nov 2025

Expected to finish

Mar 2027

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ≥ 18 years. * Voluntary signed informed consent. * Confirmed diagnosis of diffuse toxic goiter (Graves' disease). * Abnormal thyroid function tests (e.g., elevated T4, and suppressed TSH). * No prior or recent use of antithyroid medications (discontinued for at least 4 weeks). * Female participants must be postmenopausal, surgically sterile, or using a highly effective method of contraception. * Male participants must agree to practice abstinence, use a highly effective method of contraception, or have undergone vasectomy. * Ability to comply with the follow-up schedule and understand and adhere to the study requirements. Exclusion Criteria: * Non-diffuse toxic goiter-induced hyperthyroidism. * Previous radioactive iodine treatment or thyroid surgery. * History or risk of thyroid storm. * Use of thyroid hormone medications within the past 6 weeks. * accompanied by active thyroid eye disease. * Thyroid eye disease treated with radiation/surgery,or need for urgent surgery surgical or medical intervention. * Optic nerve lesions or corneal damage. * Use of steroids or immunosuppressants within the past 3 months,or those who have used biologics within 6 months * Inability to quit smoking during the study. * Allergy to the study drug or monoclonal antibodies. * Participation in another clinical trial within the past 3 months. * Abnormal electrocardiogram. * Significant hepatic or renal dysfunction. * Pregnancy,breastfeeding,or positive pregnancy test. * Positive for HIV,syphilis,hepatitis B,or hepatitis C. * History of drug or substance abuse. * Other autoimmune diseases requiring treatment. * History of malignant tumors. * Splenectomy or major surgery within the past 6 months. * Severe cardiovascular,pulmonary,hepatic,renal,neurological,or hematological diseases. * Other conditions deemed unsuitable by investigators.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for GENSCI098 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110801, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.