A Study of GensSci098 in Subjects With Graves' Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
GenSci098
Drug* 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
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: GenSci098Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
141 daysSponsors and contacts
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Source ClinicalTrials.gov