Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147

This Phase I clinical study is a randomized, double-blind, placebo-controlled,
parallel-design study to thoroughly assess the safety profile and PK properties of J147 in
healthy subjects. The study will include single ascending dose (SAD) in healthy young and
elderly subjects.

Approximately 64 subjects may be included in the study, with an additional 24 to be added
depending on the emerging data.

Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and
female subjects are planned. Depending on emerging safety, tolerability and PK data, 2
additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of
8 elderly male and female subjects may be enrolled.

In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2
subjects will be randomized to receive a matching dose of placebo.

All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1
subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will
receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours
following the sentinel subjects.

Healthy elderly subjects will receive doses that have been found to be safe in healthy young
subjects.

Inclusion Criteria:

- Provide voluntarily agreement to participate in this study and signs an
IRB/IEC-approved informed consent prior to performing any of the screening procedures

- Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of
signing the informed consent; OR, Healthy male and female subjects, between 60 to 85
years of age, inclusive, at the time of signing the informed consent

- If male, subjects with partners of child bearing potential must be practicing
abstinence, part of an abstinent life style or agree to use a highly effective
contraception method during the intervention period and for at least 3 months after
the last dose of study medication and refrain from donating sperm during this period.
Because of the unacceptable failure rate of barrier (chemical and/or physical)
methods, the barrier method of contraception must only be used in combination with a
highly effective method. Post coital methods of contraception are not permitted.

- If female, must not be pregnant, must not be lactating, and must be of
non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal
ligation] or postmenopausal ≥ 1 year.

- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with a
weight of at least 50 kg

- Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the
past year) and by urine cotinine concentration (< 200 ng/mL) at the screening visit
and admission

Exclusion Criteria:

- Has clinically significant history or evidence of cardiovascular, endocrine,
hematologic, immune, gastrointestinal, genitourinary or other body system disease as
determined by an Investigator

- Has clinically significant history or evidence of disease or dysfunction in
neurological or psychiatric system that is likely to affect the results of the study
in the opinion of an Investigator

- Has any disorder that would interfere with the absorption, distribution, metabolism or
excretion of drugs

- Subject has any concurrent disease or condition that, in the opinion of the Principal
Investigator, would make the subject unsuitable for participation in the clinical
study

- Has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV)
or human immunodeficiency virus (HIV) antibodies

- Has a urine blood test for ethanol or cotinine at the screening visit or admission

- Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates,
benzodiazepines, cannabinoids) at the screening visit or admission

- Females who are breastfeeding

- Is unwilling to or has not avoided consumption of grapefruit, grapefruit juice,
Seville oranges, Seville orange marmalade or other products containing grapefruit or
Seville oranges within 14 days of dosing with study medication

- Has history of alcohol and/or illicit drug abuse within 1 year of entry or is
unwilling to avoid use of alcohol or alcohol-containing foods, medications or
beverages, within 48 hours prior to admission until discharge from the clinical unit

- Has donated blood (> 500 mL) or blood products within 30 days prior to first day of
dosing

- Requires treatment with any medication, prescription or over-the-counter (OTC)
medications (including vitamins [mega doses], dietary supplements or herbal
medications), prescription medications within 14 days prior to administration of study
medication. By exception, acetaminophen ≤ 1000 mg per day and vitamin products at
recommended daily doses are permitted

- Has received any known hepatic or renal clearance altering agents (e.g., erythromycin,
cimetidine, barbiturates, phenothiazines or herbal/plant-derived preparations such as
St. John's wort) for a period of 30 days prior to dosing

- Has used an investigational drug within 30 days prior to screening

- Has a history of hypersensitivity or allergies to J147, any components of formulated
J147, or any drug within the same class; minor drug allergies to a drug in another
drug class may be approved by an Investigator if not considered of clinical relevance

- Has clinically significant abnormal vital signs, 12-lead ECGs, physical examination,
clinical laboratory, or other safety variable, as judged by an Investigator

- Is considering or has scheduled any surgical procedure during study participation

- Requires a special diet or has a significant food allergy or intolerance; if the
subject or patient is vegetarian, he or she may be enrolled at an Investigator's
discretion

- Is unable to understand the protocol requirements, instructions and study related
restrictions, the nature, scope and possible consequences of the clinical study

- Is unlikely to comply with the protocol requirements, instructions and study related
restrictions; e.g., uncooperative attitude, inability to return for follow-up visits
and improbability of completing the clinical study

- Has previously been enrolled in this clinical study or is currently enrolled in
another clinical study

- For the elderly subjects, there must be no evidence of cognitive decline that has been
greater than expected for age and no evidence of changes in their level of
independence in everyday life.

- Is judged by an Investigator or Sponsor to be inappropriate for the study