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InflammationPhase 1/2AvenActiveNCT06101784

Single and Multiple Ascending Oral Doses of Avenanthramide

A Phase 1/2 study testing Avenanthramide in people with Inflammation, run by Montreal Heart Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Inflammation
What is being tested?
Avenanthramide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteCanada
Study dates
9 Dec 2023to 16 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 during study participation;
  • 5. Willing to avoid oat consumption for 1 week prior to the first drug administration and during study participation;
  • 6. Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 6 months prior to the first study drug administration;
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  • 7. Non- or ex-consumer of cannabis; an ex-consumer of cannabis is defined as someone who stopped using cannabis derived products for at least 6 months prior to the first study drug administration;
  • 8. Have no clinically significant diseases captured in the medical history and no evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by the investigator;
  • 9. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by the investigator;
  • 10. Provision of signed and dated informed consent form (ICF);
  • 11. Stated willingness to comply with all study procedures and availability for the duration of the study;
  • 12. A male subject meeting one of the following criteria:
  • Subject is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:
  • True abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (not periodic abstinence)
  • Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) If the subject has a partner of childbearing potential, he and/or his partner must agree to use two acceptable birth control methods.
  • Or
  • Subject is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 6 months prior to the first study drug administration)
  • 13. A female subject meeting one of the following criteria:
  • Subject of childbearing potential must agree to use an effective double method of birth control from the first study drug administration to at least 30 days after the last drug administration: barrier method (e.g., male or female condoms, spermicides, sponges, foams, jellies, and diaphragm) in combination with other methods of contraception including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices; or must have a sterile sexual partner.
  • Or
  • Subject is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject (not periodic abstinence) Or
  • Subject is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a menopausal state (i.e., at least 1 year without menses prior to the first study drug administration).
  • Part-C:
  • In addition to the above criteria, the inclusion criterion #2 is defined as following:
  • 2. Body mass index (BMI) within 18.5 kg/m2 to 34.0 kg/m2, inclusively, for the subjects participating in Part C.
  • Also, subjects with elevated waist circumference and low-grade inflammation must meet the following criteria in order to be included in the study:
  • Waist circumference ≥ 100 cm in men and ≥ 85 cm in women
  • Hs-CRP equal or greater than 2.0 mg/L and less than 10.0 mg/L at Screening

Who cannot join

  • 1. Allergy to any ingredient of the Investigational Products, including excipients;
  • 2. Oat products consumption within 1-week prior the first drug administration;
  • 3. History of significant hypersensitivity to any excipients of the formulation, as well as severe hypersensitivity reactions (like angioedema) to any drug;
  • 4. Presence of significant gastrointestinal (GI) conditions that interfere with absorption;
  • 5. Presence of significant cardiovascular disease, gastrointestinal disease, kidney disease, or endocrine disease: including diabetes, and untreated thyroid disease, or rheumatoid arthritis;
  • 6. Diagnosis of Gilbert syndrome;
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  • 7. Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg at screening;
  • 8. Major trauma or surgery within 3 months of study participation;
  • 9. Presence of clinically significant ECG abnormalities at the screening, as defined by medical judgment;
  • 10. Any clinically significant illness in the 28 days prior to the first study drug administration;
  • 11. Any history of tuberculosis or proven contact with tuberculosis;
  • 12. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration;
  • 13. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HbsAg (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests at screening;
  • 14. Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to the first drug administration;
  • 15. Use of any prescription drugs (with the exception of contraceptive or hormone replacement therapy) in the 28 days prior to the first study drug administration;
  • 16. Regular use of anti-inflammatory drugs such as NSAIDs or aspirin in the 28 days prior to the first study drug administration;
  • 17. Rigorous physical activity the day prior the first drug administration;
  • 18. Nicotine smoking and/or nicotine replacement use;
  • 19. Drinking alcohol >10 drinks/week, or history of drug abuse;
  • 20. Strict dietary restrictions (such as ketogenic or vegan diet);
  • 21. Regular use of nutraceuticals such as resveratrol, immune boosters, glucosamine, chondroitin, Coenzyme Q10 supplementation in the 28 days prior to the first study drug administration;
  • 22. Regular use of plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), in the 28 days prior to the first drug administration;
  • 23. Females who are lactating or are pregnant according to the pregnancy test at screening or prior to the first study drug administration;
  • 24. Subjects who have already been included in a previous group/cohort for this clinical study;
  • 25. Subjects who took an Investigational Product (IP) in the 28 days prior to the first study drug administration;
  • 26. Subjects who donated 50 mL and up to 450 mL of blood in the 28 days prior to the first study drug administration;
  • 27. Donation of 450 mL or more of blood (Canadian Blood Services, Hema Quebec, clinical studies, etc.) in the 2 months prior to the first study drug administration for males, and in the 3 months prior to the first drug administration for females.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1N6

Other trials in Canada

About this study

Official title: 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

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.

Read more

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
Being tested
Avenanthramide, Placebo
Keywords
Healthy subjects, Single ascending dose, Multiple ascending dose, Natural product, Placebo controlled, First in human
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvenanthramideDrug

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

  • PlaceboDrug

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

Study groups in NCT06101784
Study groupRoleWhat they receive
Avenanthramide tablet single oral doseActive comparatoradaptive dose levels
Receives: Drug: Avenanthramide
Placebo to match Avenanthramide tablet single oral dosePlacebo comparatoradaptive dose levels
Receives: Drug: Placebo
Avenanthramide tablet multiple oral doseActive comparatoradaptive dose levels
Receives: Drug: Avenanthramide
Placebo to match Avenanthramide tablet multiple oral dosePlacebo comparatoradaptive dose levels
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (Safety and Tolerability)

    Incidence of AEs on active treatment compared to placebo

    Measured: from drug administration up to 24 hours after the last dose

  2. Change in laboratory parameters (general biochemistry)

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

    Measured: from drug administration up to 24 hours after the last dose

  3. Change in laboratory parameters (general biochemistry)

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

    Measured: from drug administration up to 24 hours after the last dose

  4. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Total bilirubin (umol/L)

    Measured: from drug administration up to 24 hours after the last dose

  5. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Direct bilirubin (umol/L)

    Measured: from drug administration up to 24 hours after the last dose

  6. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters :Indirect bilirubin (umol/L)

    Measured: from drug administration up to 24 hours after the last dose

  7. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Serum urea (mmol/L)

    Measured: from drug administration up to 24 hours after the last dose

  8. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Serum creatinine (umol/L)

    Measured: from drug administration up to 24 hours after the last dose

  9. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : eGFR (mL/min/1.73 mE2)

    Measured: from drug administration up to 24 hours after the last dose

  10. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Blood urea nitrogen (mg/dL)

    Measured: from drug administration up to 24 hours after the last dose

  11. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Fasting glucose (mmol/L)

    Measured: from drug administration up to 24 hours after the last dose

  12. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Fasting plasma insulin (pmol/L)

    Measured: from drug administration up to 24 hours after the last dose

  13. Change in laboratory parameters (general biochemistry)

    The change in serum laboratory parameters : Total cholesterol (mmol/L))

    Measured: from drug administration up to 24 hours after the last dose

  14. Change in laboratory parameters (hematology)

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

    Measured: from drug administration up to 24 hours after the last dose

  15. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Erythrocytes (10E12/L)

    Measured: from drug administration up to 24 hours after the last dose

  16. Change in laboratory parameters (hematology)

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

    Measured: from drug administration up to 24 hours after the last dose

  17. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Hemoglobin (g/L)

    Measured: from drug administration up to 24 hours after the last dose

  18. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Hematocrit (L/L)

    Measured: from drug administration up to 24 hours after the last dose

  19. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Mean corpuscular volume (fL)

    Measured: from drug administration up to 24 hours after the last dose

  20. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Mean corpuscular hemoglobin (pg)

    Measured: from drug administration up to 24 hours after the last dose

  21. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Mean corpuscular hemoglobin concentration (g/L)

    Measured: from drug administration up to 24 hours after the last dose

  22. Change in laboratory parameters (hematology)

    The change in serum laboratory parameters: Mean platelet volume (fL)

    Measured: from drug administration up to 24 hours after the last dose

  23. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: head and neck

    Measured: from drug administration up to 24 hours after the last dose

  24. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: cardiovascular

    Measured: from drug administration up to 24 hours after the last dose

  25. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: respiratory

    Measured: from drug administration up to 24 hours after the last dose

  26. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: abdomen

    Measured: from drug administration up to 24 hours after the last dose

  27. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: brief neurological appearance

    Measured: from drug administration up to 24 hours after the last dose

  28. Change in physical examination (Safety and Tolerability)

    The change in review of body systems: brief general appearance

    Measured: from drug administration up to 24 hours after the last dose

  29. Change in vital signs (Safety and Tolerability)

    The change in pulse rate (pbm)

    Measured: from drug administration up to 24 hours after the last dose

  30. Change in vital signs (Safety and Tolerability)

    The change in blood pressure (mm Hg)

    Measured: from drug administration up to 24 hours after the last dose

  31. Change in vital signs (Safety and Tolerability)

    The change in body temperature (degrees Celsius).

    Measured: from drug administration up to 24 hours after the last dose

  32. Change in ECG parameters (Safety and Tolerability)

    The change in ECG parameters: PR interval

    Measured: from drug administration up to 24 hours after the last dose

  33. Change in ECG parameters (Safety and Tolerability)

    The change in ECG parameters: QRS interval

    Measured: from drug administration up to 24 hours after the last dose

  34. Change in ECG parameters (Safety and Tolerability)

    The change in ECG parameters: QT interval

    Measured: from drug administration up to 24 hours after the last dose

Secondary outcomes (42)

  1. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 on the food-effect cohort): Cmax

    Measured: Up to 24 hours after the last dose

  2. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 on the food-effect cohort): Tmax

    Measured: Up to 24 hours after the last dose

  3. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): AUC0-T

    Measured: Up to 24 hours after the last dose

  4. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): AUC0-∞,

    Measured: Up to 24 hours after the last dose

  5. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): AUC 0-T/∞

    Measured: Up to 24 hours after the last dose

  6. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): λz

    Measured: Up to 24 hours after the last dose

  7. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): T1/2

    Measured: Up to 24 hours after the last dose

  8. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): CL/F*

    Measured: Up to 24 hours after the last dose

  9. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD])

    Plasma Day 1 (and Day 8 for food effect only): VD/F*

    Measured: Up to 24 hours after the last dose

  10. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD]):

    Urine Day 1 (and Day 8 on the food-effect cohort): Ae

    *for parent drug only:

    Measured: Up to 24 hours after the last dose

  11. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD]):

    Urine Day 1 (and Day 8 on the food-effect cohort): Fe*

    *for parent drug only:

    Measured: Up to 24 hours after the last dose

  12. The change in Pharmacokinetics

    Part A (Single Ascending Dose [SAD]):

    Urine Day 1 (and Day 8 on the food-effect cohort): Clr*

    *for parent drug only:

    Measured: Up to 24 hours after the last dose

  13. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 1: Cmax

    Measured: Up to 24 hours after the last dose

  14. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 1: Tmax

    Measured: Up to 24 hours after the last dose

  15. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 1: AUC0-12

    Measured: Up to 24 hours after the last dose

  16. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Days 2 (prior to AM and PM dose), and 3 (prior to AM dose): Ctrough

    Measured: Up to 24 hours after the last dose

  17. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: Cmax

    Measured: Up to 24 hours after the last dose

  18. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: Tmax

    Measured: Up to 24 hours after the last dose

  19. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: Cmin

    Measured: Up to 24 hours after the last dose

  20. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: AUC0-24

    Measured: Up to 24 hours after the last dose

  21. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: AUCtau

    Measured: Up to 24 hours after the last dose

  22. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: T1/2

    Measured: Up to 24 hours after the last dose

  23. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: Rac(Cmax)

    Measured: Up to 24 hours after the last dose

  24. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Plasma Day 3: Rac(AUC)

    Measured: Up to 24 hours after the last dose

  25. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Urine Day 1 (12hrs), Day 3 (12hrs and 24hrs): Ae

    • for parent drug only

    Measured: Up to 24 hours after the last dose

  26. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Urine Day 1 (12hrs), Day 3 (12hrs and 24hrs): Fe*

    • for parent drug only

    Measured: Up to 24 hours after the last dose

  27. The change in Pharmacokinetics

    Part B (Multiple Ascending Dose [MAD]) in healthy subjects:

    Urine Day 1 (12hrs), Day 3 (12hrs and 24hrs): Clr*

    • for parent drug only

    Measured: Up to 24 hours after the last dose

  28. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 1: Cmax

    Measured: Up to 24 hours after the last dose

  29. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 1: Tmax

    Measured: Up to 24 hours after the last dose

  30. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 1: AUC0-12

    Measured: Up to 24 hours after the last dose

  31. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Days 8, 15, 22 and 29 (prior to AM dose): Ctrough

    Measured: Up to 24 hours after the last dose

  32. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : Cmax

    Measured: Up to 24 hours after the last dose

  33. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : Tmax

    Measured: Up to 24 hours after the last dose

  34. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : Cmin

    Measured: Up to 24 hours after the last dose

  35. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : AUC0-24

    Measured: Up to 24 hours after the last dose

  36. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : AUCtau

    Measured: Up to 24 hours after the last dose

  37. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : T1/2

    Measured: Up to 24 hours after the last dose

  38. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : Rac(Cmax)

    Measured: Up to 24 hours after the last dose

  39. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Plasma Day 29 : Rac(AUC)

    Measured: Up to 24 hours after the last dose

  40. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Urine Day 1 (12hrs) and Day 29 (12hrs and 24hrs). Ae

    Measured: Up to 24 hours after the last dose

  41. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Urine Day 1 (12hrs) and Day 29 (12hrs and 24hrs). Fe*

    Measured: Up to 24 hours after the last dose

  42. The change in Pharmacokinetics

    Part C (MAD in subjects with elevated waist circumference and low-grade inflammation):

    Urine Day 1 (12hrs) and Day 29 (12hrs and 24hrs). Clr*

    Measured: Up to 24 hours after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start9 Dec 2023
  3. Primary completion16 Jun 2025
  4. Study completion16 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Double-Blind, Placebo-Controlled, Randomized, Adaptive, First-in-Human Study, Single and Multiple Ascending Oral Doses
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06101784
Sponsor's protocol ID
PROJ1602
Acronym
AvenActive
Status last verified
Jan 2026
First submitted
7 Aug 2023
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Avenanthramide in people with Inflammation, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (Safety and Tolerability) (time frame: from drug administration up to 24 hours after the last dose). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06101784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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