Surrozen, Inc. announced that the first subject has been dosed in its three-part Phase 1 clinical trial to evaluate SZN-1326 for the potential treatment of moderate to severe ulcerative colitis. The trial initiation is approximately one quarter earlier than previously expected. Surrozen also recently announced the publication of an article by Surrozen scientists in the journal Cellular and Molecular Gastroenterology and Hepatology The results highlight the potential for this novel approach to treating inflammatory bowel disease.

The Phase 1, randomized, placebo-controlled, single- and multiple-ascending-dose study will evaluate the safety, pharmacokinetics, and activity of SZN-1326. The first part of the trial will evaluate single doses of SZN-1326 via intravenous injection or infusion, or subcutaneous injection in healthy volunteers, progressing from 25 mg through 1500 mg. The second part will evaluate multiple ascending doses of SZN-1326 for a period of four weeks in healthy volunteers, with each subject assigned to one of three dose level cohorts increasing from 75 mg IV up to 750 mg IV.

The primary endpoint of Parts 1 and 2 of the trial are safety and tolerability of SZN-1326 and secondary outcomes include pharmacokinetics as well as prevalence of Anti-Drug Antibodies (ADA).