New injection for Graves' disease enters first human tests
NCT ID NCT07286656
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of China Medical University
RECRUITINGShenyang, Liaoning, 110801, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Why does Graves' disease leave some brains exhausted? scientists hunt for clues in blood and spinal fluid
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