Ceapro Inc. announced the commencement of patient dosing in its Phase 1-2a study evaluating its product, avenanthramides, for potential applications in managing conditions related to inflammation. No adverse reactions have been observed and the study can be pursued as per protocol design. The Phase 1-2a study (AvenActive) is a double-blind, placebo-controlled, randomized, adaptive, first-in-human study designed to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of avenanthramide.

72 healthy subjects will be enrolled in the Phase 1 portion of the trial. The single ascending dose (SAD) arm will include 6 cohorts of 8 healthy subjects, while the multiple ascending dose (MAD) arm will include 3 cohorts of 8 healthy subjects. Following the Phase 1 portion, pending successful results, the AvenActive protocol also includes a Phase 2a portion for patients presenting evidence of mild to moderate inflammation.

24 patients would be enrolled in the Phase 2a portion. The Phase 1-2a trial is designed to evaluate the safety profile of avenanthramides and gather initial insights into its potential efficacy. As the trial progresses, Ceapro remains focused on collaborating with regulatory authorities, healthcare professionals, and patient communities to bring this innovative therapy to market.