A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Summary

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).

Timeline

Start

2023-10-24

Primary completion

2024-10-16

Completion

2024-11-08

Publications

• Jairath V, Danese S, D'Haens GR, Feagan BG, Peyrin-Biroulet L, Sands BE, Gaemers I, Westfall M, Terry AQ, Roberts KJ, Barbat S, Wedel P, Benson JM, Sattler C. Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):34-45. doi: 10.1016/S2468-1253(25)00296-1. Epub 2025 Nov 13.

Drugs

Indications