SafetyPhase 1NCT06569758
A Study of GenSci098 in Subjects With Active Thyroid Eye 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 and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Safety, Tolerability, GenSci098
- What is being tested?
- GenSci098
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2024to 13 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).
- Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.
- Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.
- Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.
- Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.
- Participants must be euthyroid with the underlying disease under control, or have mild hypo- or hyperthyroidism at screening. (Only applicable to Part 1)
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- Participants must have normal thyroid function or hyperthyroidism due to GD at screening. (Only applicable to Part 2)
- No prior treatment with antithyroid medications and/or thyroid hormone replacement therapy, or having taken antithyroid medications and/or thyroid hormone replacement therapy on a stable dose, or having not been treated with antithyroid medications and/or thyroid hormone replacement therapy due to intolerable side effects.
- Anyone who will not be required to need or receive any immediate or planned surgical ophthalmological intervention, corrective surgery or orbital irradiation during the study.
- Female participants must meet one of the following conditions to be eligible for the study:
- Infertile, defined as surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or bilateral oophorectomy) at least 6 weeks prior to administration or menopausal (spontaneous amenorrhea ≥ 12 months which is not caused by underlying diseases and confirmed by serum follicle stimulating hormone [FSH] level ≥ 40 mIU/mL).
- Fertile female participants agree, from the start of the screening visit until 300 day after the last dose, to consistently and correctly use one of the following acceptable methods of effective contraception:
- Complete abstinence (based on the participant's preference and usual lifestyle).
- Use of oral contraceptives (estrogen and progesterone), and being on a stable dose of the same contraceptive medication for at least 3 months prior to study treatment.
- Injectable or implantable hormonal contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate < 1%), such as a hormonal vaginal ring or transdermal hormonal contraception. 4) Vasectomized partner, with the procedure performed at least 6 months ago.
- Male participants must meet one of the following criteria to be eligible for the study:
- 1) agree to use a condom plus an effective method of contraception (i.e., hormonal contraception initiated at least 30 days prior to administration; or placement of an IUD or IUS) when engaging in sexual activity with a female partner of childbearing potential from the start of the screening visit until 24 weeks after the last dose and refrain from donating sperm during this period.
- 2) agree to practice abstinence from the start of the screening visit until 24 weeks after the last dose.
- 3) have had a vasectomy at least 6 months prior to study treatment. 12. Voluntarily sign the ICF and be able to understand and comply with the study's treatment regimen and assessments until the end of the study
Who cannot join
- Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- Corneal injury not relieved by medical management.
- Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.
- Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.
- Previous orbital irradiation or surgery for TED.
- Use of any steroid (either intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for TED within 4 weeks prior to screening (discontinued steroid eye drops arepermitted).
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- Use of steroids for conditions other than TED within 4 weeks prior to screening (topical steroids for dermatological conditions and inhaled steroids are permitted).
- Drug therapy with biologics or peptides, including teprotumumab, rituximab, or tocilizumab, within 6 months or 5 half-lives of the drug (whichever is longer) prior to screening.
- Use of any non-steroidal immunosuppressive agents within the 3 months prior to screening.
- Pre-existing ophthalmic disease or autoimmune disease (other than TED) that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.
- History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or current or previous history of thyroid storm. (Only applicable to Part 2)
- History of radioiodine treatment or thyroidectomy within 6 months prior to first dose. (Only applicable to Part 2)
- Individuals who cannot abstain from smoking/tobacco products from the screening period to the end of the study.
- Any known allergy to the components of the investigational product or analogues or previous allergic reactions to monoclonal antibodies.
- Known history /diagnosis of malignancy.
- Acute/chronic infection within 2 weeks prior to screening.
- Participation in another clinical trial within 3 months before screening (except those who did not receive any intervention), or within 5 half-lives of the study drug in other clinical trials (whichever is longer), or concurrent enrollment in another clinical trial.
- Those with prolonged QTcF interval in 12-lead ECG results (> 450 ms for males, > 460 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening that, in the investigator's judgment, may affect trial participation;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3 times the ULN, or total bilirubin (TBIL) or alkaline phosphatase (ALP) > 2 × ULN, blood creatinine (Cr) ≥ 1.5 times the ULN at screening.
- Positive blood pregnancy test, or lactating women at the time of screening.
- Positive for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum particle agglutination (TPPA) test, or hepatitis B surface antigen (HbsAg) at screening.
- History of recreational drug use or substance abuse or positive drug screening results at screening.
- Any medical (including other clinically significant abnormal laboratory test parameters) or other conditions that the investigator believes might affect the conduct of the clinical trial.
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
Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medication
Shanghai, Shanghai Municipality, 200011
Huifang Zhou, +8613661901886, fangzzfang@sjtu.edu.cn
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Read the detailed description
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
- Conditions
- Safety, Tolerability, GenSci098, Thyroid Eye Disease (TED)
- Being tested
- GenSci098, GenSci098 Placebo
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci098Drug
subcutaneous , 5 dose levels(15mg, 45mg, 90mg, 180mg and 270mg) will be assigned.
GenSci098 PlaceboDrug
In SAD part only one dose of GenSci098 and GenSci098 Placebo to be given, in MAD part, multiple doses of GenSci098 and GenSci098 Placebo will be given.
| Study group | Role | What they receive |
|---|---|---|
| GenSci098 | Experimental | Not described Receives: Drug: GenSci098 |
| GenSci098 Placebo | Placebo comparator | Not described Receives: Drug: GenSci098 Placebo |
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]).
Measured: SAD Part: 169 days, MAD Part: 281 days
Secondary outcomes (8)
PK parameters after single and multiple subcutaneous doses of GenSci098: maximum concentration at steady state (Cmax,ss);
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: minimum concentration at steady state (Cmin,ss);
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: time to maximum concentration at steady state (Tmax,ss);
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: average concentration at steady state (Cav,ss);
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: area under the concentration-time curve at steady state (AUC0-τ,ss);
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: apparent clearance CL/F
Measured: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: half life t1/2,
Measured: SAD Part: 169 days, MAD Part: 281 days
Incidences of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), and titer of ADA.
Measured: SAD Part: 169 days, MAD Part: 281 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start24 Sep 2024
- Primary completion2 Sep 2027 (estimated)
- Study completion13 Dec 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huifang Zhou, PHD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569758
- Sponsor's protocol ID
- GenSci098-101
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients
- ClinicalTrials.gov ID
- NCT06569758
- Acronym / sponsor ID
- GenSci098-101
- Conditions
- Safety, Tolerability, GenSci098, Thyroid Eye Disease (TED)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 13 Dec 2027 (estimated)
- First posted
- 26 Aug 2024 (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 and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Detailed description
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci098 | Experimental | Drug: GenSci098 |
| GenSci098 Placebo | Placebo comparator | Drug: GenSci098 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).
- Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.
- Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.
- Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.
- Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.
Key exclusion criteria (23 listed)
- Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- Corneal injury not relieved by medical management.
- Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.
- Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.
- Previous orbital irradiation or surgery for TED.
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 |
|---|---|---|
| GenSci098subcutaneous , 5 dose levels(15mg, 45mg, 90mg, 180mg and 270mg) will be assigned. | Drug | GenSci098 |
| GenSci098 PlaceboIn SAD part only one dose of GenSci098 and GenSci098 Placebo to be given, in MAD part, multiple doses of GenSci098 and GenSci098 Placebo will be given. | Drug | GenSci098 Placebo |
Primary outcome
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
Time frame: SAD Part: 169 days, MAD Part: 281 days
8 secondary outcomes
PK parameters after single and multiple subcutaneous doses of GenSci098: maximum concentration at steady state (Cmax,ss);
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: minimum concentration at steady state (Cmin,ss);
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: time to maximum concentration at steady state (Tmax,ss);
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: average concentration at steady state (Cav,ss);
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: area under the concentration-time curve at steady state (AUC0-τ,ss);
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: apparent clearance CL/F
Time frame: SAD Part: 169 days, MAD Part: 281 days
PK parameters after single and multiple subcutaneous doses of GenSci098: half life t1/2,
Time frame: SAD Part: 169 days, MAD Part: 281 days
Incidences of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), and titer of ADA.
Time frame: SAD Part: 169 days, MAD Part: 281 days
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 11 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.
Huifang Zhou, PHD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 19 inclusion and 23 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 11 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. Some participants in this study may receive a placebo. 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 Jun Yan (+8615800359085, yanjun01@genscigroup.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: SAD Part: 169 days, MAD Part: 281 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 11 Feb 2026.