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

What this Trial Is About

Researchers are evaluating GenSci098, a drug given as single ascending subcutaneous doses, in adults with Graves Disease to study its safety and tolerability. This phase 1 clinical trial aims to understand the effects of GenSci098 on patients with confirmed diffuse toxic goiter and abnormal thyroid function. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on monitoring adverse events and drug behavior in the body. Participants will receive only one dose of GenSci098 injected under the skin at one of several dose levels. The study includes a follow-up period lasting 141 days, during which safety and tolerability will be assessed. There is no placebo or control group, and the trial is not blinded. The focus is on careful monitoring after the single dose administration. Throughout the study, participants will undergo physical exams, vital sign checks, laboratory tests, and 12-lead electrocardiograms to detect any adverse effects. Researchers will track the incidence and severity of adverse events during the 141-day observation window. Participants must comply with the follow-up schedule and study requirements to ensure accurate safety monitoring and data collection.

A Study of GensSci098 in Subjects With Graves' Disease