Phase 1 Study of GenSci098 Safety and Tolerability in Adults With Active Thyroid Eye Disease

What this Trial Is About

Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease TED related to Graves disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels 15mg, 45mg, 90mg, 180mg, or 270mg or a matching placebo. The study includes two parts a single ascending dose SAD phase where participants receive one dose, and a multiple ascending dose MAD phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.

A Study of GenSci098 in Subjects With Active Thyroid Eye Disease