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A Phase II, Randomized, Double -blind, Placebo -controlled ...

Date: 16 May 2017 Supersedes: Page 1 of 97 TJ301 Protocol No.: CTJ301UC201 Solution for Injection Clinical Trial Protocol Leading Biopharm Limited CONFIDENTIAL CLINICAL TRIAL PROTOCOL A Phase II, Randomized, Double - blind , Placebo -controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis Protocol Number: CTJ301UC201 Investigational Medicinal Product: TJ301 (solution for injection), also referred to as FE 999301 and Olamkicept Indication: Active Ulcerative Colitis Phase : 2 Investigators: multicenter , international, across Mainland China, Taiwan, Republic of Korea and Australia Coordinating Investigator Prof. Dr. Minhu Chen Chair, Department of Gastroenterology and Hepatology Vice President The First Affiliated Hospital, Sun Yat-sen University 58 Zhongshan Road, Guangzhou, China Expert committee Prof.

This is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.

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