A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU

Inclusion Criteria6

• Participants must be capable of understanding the trial procedures, voluntarily agree to participate, communicate effectively with the investigators, comply with all study requirements throughout the trial, and provide written Informed consent Form (ICF);
• At screening visit, male or female paticipants aged 18-70 years (inclusive) ;
• At screening visit, Body mass index (BMI) between 18 and 30 kg/m² (inclusive), with a body weight of ≥50 kg for males and ≥45 kg for females;
• At screening, at least one eye was diagnosed with active non-infectious uveitis by the investigator, including non-infectious intermediate uveitis, posterior uveitis, or panuveitis;
• Subject must have active disease at the screening and baseline visit, as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent):
• \) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria) 3) ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria) ; \[6\] Participants and their partners must have no plans for reproduction, sperm donation, or egg donation from the start of treatment until at least one month after the last dose of the investigational drug, and must voluntarily employ an effective method of contraception as determined by the investigator.