Single and Multiple Ascending Oral Doses of Avenanthramide

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 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;
• •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:
• •1. 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
• •2. 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:
• •1. 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
• •2. 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
• •3. 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