A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease

Recruiting Phase 2 Interventional Study
Adult Patients With Moderately to Severely Active Ulcerative Colitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Shandong Suncadia Medicine Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male and female subject age ≥ 18,≤75. 2. the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ². 3. 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 cent…
Contacts

Tingyu Dong

0518-82342973

tingyu.dong@hengrui.com

CONTACT