SafetyPhase 1NCT07286656
A Study of GensSci098 in Subjects With Graves' Disease
A Phase 1 study testing GenSci098 in people with Safety and Tolerability, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety, Tolerability, GenSci098
- What is being tested?
- GenSci098
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2025to 18 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110801
Zhongyan Shan, PHD, +86 24 8328 2152, shanzhongyan@hotmail.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
- Conditions
- Safety, Tolerability, GenSci098, Graves Disease
- Being tested
- GenSci098
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci098Drug
- Administration: Only one dose of GenSci098 will be given.
- Route of Administration: Subcutaneous (injected under the skin).
- Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4
| Study group | Role | What they receive |
|---|---|---|
| GenSci098 | Experimental | Not described Receives: Drug: GenSci098 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
This outcome measure assesses the incidence and severity of adverse events (AEs) experienced by participants during the study. AEs will be monitored through physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms (ECGs). The assessment period spans from the first dose of the study intervention to 141 days post-dosing.
Measured: 141 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start21 Nov 2025
- Primary completion28 Oct 2026 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongyan Shan, PHD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286656
- Sponsor's protocol ID
- GenSci098-102
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Dose of GenSci098 in Patients With Graves' Disease
- ClinicalTrials.gov ID
- NCT07286656
- Acronym / sponsor ID
- GenSci098-102
- Conditions
- Safety, Tolerability, GenSci098, Graves Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenSci098 | Experimental | Drug: GenSci098 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci098* Administration: Only one dose of GenSci098 will be given. * Route of Administration: Subcutaneous (injected under the skin). * Dose Levels: • Dose 1 • Dose 2• Dose 3• Dose 4 | Drug | GenSci098 |
Primary outcome
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
Time frame: 141 days
This outcome measure assesses the incidence and severity of adverse events (AEs) experienced by participants during the study. AEs will be monitored through physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms (ECGs). The assessment period spans from the first dose of the study intervention to 141 days post-dosing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongyan Shan, PHD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci098 in people with Safety and Tolerability, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongyan Shan, PHD (+86 24 8328 2152, shanzhongyan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]). (time frame: 141 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.