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Avenanthramide

Phase 1

Inflammation | Small molecule | Immunology |COSCIENS Biopharma Inc.|Trials Updated: Apr 20, 2026

Avenanthramide development status

Highest phase Phase 1

Registered trials 1 across 1 sponsor since Oct 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC

Total Trials1

Total Enrollment92

FDA Designations

No designations recorded

Avenanthramide clinical trials

Avenanthramide · 1 trial · 1 indication

Phase 1 1

NCT06101784Single and Multiple Ascending Oral Doses of AvenanthramideInflammation

COMPLETED92 Analytics

PHASE1COMPLETED

Single and Multiple Ascending Oral Doses of Avenanthramide

Inflammation

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Study Endpoints

Primary Endpoints

Incidence of Adverse Events (Safety and Tolerability)

from drug administration up to 24 hours after the last dose

Incidence of AEs on active treatment compared to placebo

Change in laboratory parameters (general biochemistry)

from drug administration up to 24 hours after the last dose

The change in serum laboratory parameters : Alanine aminotransferase (IU/L)

Change in laboratory parameters (hematology)

from drug administration up to 24 hours after the last dose

The change in serum laboratory parameters: (Leucocytes (10E9/L)

Change in physical examination (Safety and Tolerability)

from drug administration up to 24 hours after the last dose

The change in review of body systems: head and neck

Change in vital signs (Safety and Tolerability)

from drug administration up to 24 hours after the last dose

The change in pulse rate (pbm)

Change in ECG parameters (Safety and Tolerability)

from drug administration up to 24 hours after the last dose

The change in ECG parameters: PR interval

Secondary Endpoints

The change in Pharmacokinetics

Up to 24 hours after the last dose

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Avenanthramide tablet single oral dose	ACTIVE_COMPARATOR	adaptive dose levels
Placebo to match Avenanthramide tablet single oral dose	PLACEBO_COMPARATOR	adaptive dose levels
Avenanthramide tablet multiple oral dose	ACTIVE_COMPARATOR	adaptive dose levels
Placebo to match Avenanthramide tablet multiple oral dose	PLACEBO_COMPARATOR	adaptive dose levels

Interventions

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

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Eligibility Criteria

Age Range18 Years to 60 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * 1\. Male or female subjects; * 2\. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively, for subjects participating in Part A and Part B; * 3\. Age 18-60 years; * 4\. Willing to avoid rigorous physical activity 1 day prior to the first drug administration and dur...

Countries:Canada

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