MedTrace Logo

Single and Multiple Ascending Oral Doses of Avenanthramide

NCT06101784 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

Placebo

In each cohort 6 subjects will be assigned to the active treatment and 2 subjects will be assigned to the placebo.

DRUG

Avenanthramide

In each cohort 6 subjects will be assigned to the active treatment and 2 subjects will be assigned to the placebo.

Sponsors & Collaborators

  • Ceapro Inc.

    collaborator INDUSTRY

  • The Montreal Health Innovations Coordinating Center (MHICC)

    collaborator OTHER

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Jean-Claude Tardif, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-09
Primary Completion
2025-06-16
Completion
2025-06-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101784 on ClinicalTrials.gov