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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.

• International Conference on Harmonisation, E6 Good Clinical Practice: Consolidated Guideline. • All applicable laws and regulations, including, without limitation, data privacy laws and regulations. • Regulatory requirements for reporting serious …

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ATC Anatomical Therapeutic Chemical CFB change from baseline DHA dapsone hydroxylamine eCRF electronic case report form IGA Investigator’s Global Assessment MedDRA Medication Dictionary for Regulatory Activities mITT modified intent-to-treat NAD N-acetyl dapsone PK pharmacokinetic ...

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