Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

Summary

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

Timeline

Start

2021-05-05

Primary completion

2022-06-17

Completion

2022-10-05

Publications

• Verstockt B, Vermeire S, Peyrin-Biroulet L, Mosig R, Feagan BG, Colombel JF, Siegmund B, Rieder F, Schreiber S, Yarur A, Panaccione R, Dubinsky M, Lichtiger S, Cataldi F, Danese S. The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study. J Crohns Colitis. 2024 May 31;18(5):762-772. doi: 10.1093/ecco-jcc/jjad192.

Drugs

Indications