NCT06101784

Single and Multiple Ascending Oral Doses of Avenanthramide

A Double-Blind, Placebo-Controlled, Randomized, Adaptive, First-in-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Avenanthramide

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Avenanthramides (AVA) are di-phenolic compounds found only in oats and are of interest due to suggested bioactivities, including antioxidant and anti-inflammatory effects in vitro and in vivo. Published data suggests that polyphenols can work as modifiers of signal transduction pathways to elicit their beneficial effects. These natural compounds express anti-inflammatory activity by modulation of pro-inflammatory gene expression such as cyclo-oxygenase, lipoxygenase, nitric oxide synthases and several pivotal cytokines, mainly by acting through nuclear factor-kappa B and mitogen-activated protein kinase signaling. The biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein) are of particular interest. Primary Objectives: * To assess the safety and tolerability of single ascending oral doses of avenanthramide in healthy subjects. * To assess the safety and tolerability of multiple ascending oral doses of avenanthramide in healthy subjects and subjects with elevated waist circumference and low-grade inflammation. Secondary Objectives: * To determine the pharmacokinetics of avenanthramide following single ascending oral doses in healthy subjects. * To compare the pharmacokinetics of avenanthramide following single oral dose in healthy subjects under fasting and fed conditions. * To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in healthy subjects. * To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in subjects with elevated waist circumference and low-grade inflammation.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	Avenanthramide	In each cohort 6 subjects will be assigned to the active treatment and 2 subjects will be assigned to the placebo.
DRUG	Placebo	In each cohort 6 subjects will be assigned to the active treatment and 2 subjects will be assigned to the placebo.

Timeline

• Start date: 2023-12-09
• Primary completion: 2025-06-16
• Completion: 2026-03-30
• First posted: 2023-10-26
• Last updated: 2026-01-22

Locations

1 site across 1 country: Canada