Assessing J147 for Alzheimer's in Healthy Volunteers

• Healthy males age 18 to 50; healthy males and females age 60 to 85
• If male with a partner of childbearing potential, must practice abstinence or use a highly effective contraceptive method during the study and for 3 months after; must refrain from donating sperm
• If female, must not be pregnant or lactating, and must be of non-childbearing potential (surgically sterile or 1 year post menopause)
• Body mass index of 18 to 30, with a weight of at least 110 lbs
• Nonsmokers (or other nicotine use) for at least 1 year

• History or evidence of heart, endocrine, blood, immune, gastrointestinal, genital, urinary, or other body system disease
• History or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect study results
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
• Any concurrent disease or condition that would make the participant unsuitable for study participation
• Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibodies
• Positive test for ethanol (alcohol) or cotinine (tobacco) at screening or admission
• Positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at screening or admission
• Is unwilling to avoid consumption of grapefruit, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days of taking the study drug
• History of alcohol and/or illicit drug abuse in past year or is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages within 48 hours of admission until discharge from the clinical unit
• Has donated blood or blood products within 30 days of first dosing
• Requires treatment with any prescription drugs or over-the-counter medications, including vitamins (large doses), dietary supplements, or herbal medications, within 14 days of study medication (acetaminophen 1,000 mg per day and recommended daily doses of vitamins are permitted)
• Has received any known liver or kidney clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, or St. John's wort) within 30 days of study start
• Has used an investigational drug within 30 days of screening
• Hypersensitivity or allergies to J147, any of its components, or any drug within the same class
• Significant abnormal vital signs on physical exam or laboratory results
• Is considering or has scheduled any surgical procedure during study participation
• Requires a special diet or has a significant food allergy or intolerance (vegetarian diet may be permitted)
• Currently enrolled in another clinical study
• Evidence of cognitive decline that is greater than expected for participant's age or changes in level of independence in everyday life

J147 is a synthetic derivative of curcumin, a component of the curry spice turmeric. In this study participants will be randomly assigned to take either the study drug or a placebo in an escalating dose. Doses will first be given to younger participants after an 8-hour fast. Older participants will then receive doses that have been found to be safe in younger participants.

Abrexa Pharmaceuticals, Inc.

• Iqvia Pty Ltd