A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis

SOR102-101

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

2023-10-24

2024-12-01

2025-04-01

Recruiting

Early phase I

18

Key Inclusion Criteria: * Male or females, of any ethnic origin. * Established diagnosis of UC by standard criteria for \>3 months. * Disease evaluable by sigmoidoscopy. * Mildly to severely active UC as determined by central reader in combination with other assessments of disease Key Exclusion Criteria: * Any diagnosis of IBD except for UC. * History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon. * Concurrent use of any biologic drug. * Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.

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2024-04-15