This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
Male and female subject age ≥ 18，≤75.
the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read), and rectal bleeding subscore of ≥1.
Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
Treatment naïve subject diagnosed with Ulcerative Colitis.
Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.