Phase 1 Safety and PK Study of OLT1177 Capsules

Inclusion Criteria:

- Age 18 to 60 years old, inclusive

- In good health as determined by the Investigator based on subject's medical history,
ECG and physical examination at Baseline and safety laboratory tests (chemistry,
hematology, coagulation and urinalysis) at Screening

- Normal blood pressure of 130/85 mmHg or lower

- Ability to provide written, informed consent prior to initiation of any study-related
procedures, and ability, in the opinion of the Investigator, to comply with all the
requirements of the study

Exclusion Criteria:

- Women of childbearing potential, or men whose sexual partner(s) is a woman of
childbearing potential who:

1. Are or intend to become pregnant (including use of fertility drugs) during the
study

2. Are nursing

3. Are not using an acceptable, highly effective method of contraception until all
follow-up procedures are complete. (Acceptable, highly effective forms of
contraception are defined as: oral contraception, intrauterine device, systemic
[injectable or patch] contraception, double barrier methods, naturally or
surgically sterile, strict abstinence or partner has been sterilized. If
hormonal-based birth control is being used, subject or subject's sexual
partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit
and maintained at the same dosing level throughout the study.)

- Use of any drug treatment at the time of the study (with the exception of 81 mg
aspirin and prescription oral or systemic contraceptives)

- Taking any prescription medications (other than oral or systemic contraceptives)
within 14 days prior to administration of investigational drug or taking any
over-the-counter products (including natural food supplements, vitamins, garlic as a
supplement) within 14 days prior to administration of investigational drug, except
for topical products without systemic absorption

- Use of NSAIDs or other prescription pain medication, more than once or twice a week,
especially if taken for chronic or frequently recurring headache

- Active infection within 3 days of the Baseline visit

- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or
antibodies to Hepatitis C Virus (HCV)

- Diagnosed with any form of internal cancer within the past 5 years

- Any other medical conditions, diseases or prior surgeries that in the opinion of the
Investigator would impair the subject from safely participating in the trial and/or
completing any protocol requirements

- History of anaphylactic reactions to any systemic or topical compounds

- Have donated plasma (500 mL) within 7 days prior to drug administration

- Have donated or lost whole blood (excluding the volume of blood that will be drawn
during the screening procedures of this study) prior to administration of the study
medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than
499 mL of whole blood within 56 days prior to drug administration

- Is a user of any nicotine products (including chewing tobacco, snuff and/or
e-cigarettes)

- Is not willing to restrict food or beverage including: alcohol, caffeine, poppy
seeds, xanthine derivatives or xanthine-related compounds, energy drinks, natural
health products, grapefruit juice, pomelo, Seville orange and marmalade use during
the study as specified in Section 7.1.5

- Is lactose intolerant

- Is unable or unwilling to consume products containing bovine byproducts

- Is unable to adhere to or understand the requirements of the protocol

- If continuing on to Part B, subject is unable or unwilling to ingest the full
study-provided high-fat breakfast within 30 minutes

- Enrollment in any trial and/or use of any Investigational Drug or device within the
immediate 30-day period prior to the Baseline visit

- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically
Study OLT1177-01, Study OLT1177-02 or Study OLT1177-03