Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers

The Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of
orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.

The study is comprised of a total of 8 cohorts; 4 single ascending dose (SAD) cohorts, 1 Food
Effect (FE) Crossover cohort, and 3 multiple ascending dose (MAD) cohorts. Tablets will be
administered after an overnight fast (10 hours) with at least 250 mL water. No food will be
administered (exception for "fed" subjects, see below) for one hour thereafter.

Each cohort will have a total 6 subjects: SAD and MAD (2 subjects receiving placebo and 4
subjects receiving active AMXT 1501 dicaprate); and FE crossover (6 subjects receiving active
AMXT 1501 dicaprate).

SAD cohorts are defined as follows:

- Cohort 1: One placebo and one AMXT 1501 dicaprate subject will be treated as sentinel
subjects receiving one tablet each of their assigned treatment. Assuming no intolerance
is noted after at least 3 days, the remaining cohort subjects (placebo, 1 subject and
AMXT 1501 dicaprate, 3 subjects) will be treated.

- Cohort 2: 2 subjects 2 placebo each and 4 subjects 2 AMXT 1501 dicaprate tablets each

- Cohort 3: 2 subjects 4 placebos each and 4 subjects 4 AMXT 1501 dicaprate tablets each

- Cohort 4: 2 subjects 8 placebos each and 4 subjects 8 AMXT 1501 dicaprate tablets each

FE Crossover:

• Cohort 5: 6 new subjects will be randomized to a fed (n=3 standard meal) or fasted (n=3)
group and administered one dose lower of the maximum tolerated AMXT 1501 dose in the previous
SAD cohorts. First dose and accompanying assessments will be referred to as Period 1.
Subjects will then crossover to the opposite diet plan (fed or fasted) and receive a second
administration of study treatment at the same dose level. The second dose and assessments are
referred to as Period 2. There will be a 7-day washout between doses administered in Periods
1 and 2.

MAD cohorts will receive dosing once daily for 14 consecutive days. Dosing will be contingent
on adequate tolerance in Cohorts 1-5.

- Cohort 6: 2 subjects 2 placebos each; 4 subjects 2 AMXT 1501 dicaprate tablets each

- Cohort 7: 2 subjects 4 placebos each; 4 subjects 4 AMXT 1501 dicaprate tablets each

- Cohort 8: 2 subjects 8 placebos each; 4 subjects 8 AMXT 1501 dicaprate tablets each

Inclusion Criteria:

1. Adult males aged 18 to 55 years inclusive and between 18 to 30 kg/m2 body mass index
(BMI).

2. Subjects who are healthy as determined by prestudy medical history, physical
examination, and 12 Lead ECG.

3. Subjects whose clinical laboratory test results are not clinically relevant and are
acceptable to the Investigator.

4. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C
antibody and human immunodeficiency virus (HIV) I and II tests at screening.

5. Subjects who are negative for drugs of abuse and alcohol tests at screening and
admission.

6. Subjects who are non-smokers for at least 1 month preceding screening.

7. Subjects who are able and willing to give written informed consent.

Exclusion Criteria:

1. History of any important clinically significant disease or disorder which, in the
opinion of the Investigator, may either put the subject at risk because of
participation in the study, or influence the results or the subject's ability to
participate in the study.

2. History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism, or excretion
of drugs.

3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks
of the first administration of the study drug.

4. Subjects who have a history of relevant drug hypersensitivity to AMXT 1501.

5. Subjects who have a history of hearing loss.

6. Subjects who consume more than 21 units of alcohol a week. (unit = 1 glass of wine
[125 mL] = 1 measure of spirits = ½ pint of beer)

7. Subjects who have a significant infection or known inflammatory process within 2 weeks
of dosing or has febrile illness within 7 days of dosing.

8. Subjects who have acute gastrointestinal symptoms at the time of screening or
admission (e.g. nausea, vomiting, diarrhea, heartburn).

9. Subjects who have an acute infection such as influenza at the time of screening or
admission.

10. Subjects who do not agree to use medically acceptable methods of contraception during
the study and for 90 days after the last dose of study drug

11. Subjects who use any medication including antacids, analgesics (with the exception of
occasional use of up to 3 g of acetaminophen a day), herbal remedies (e.g., St. John's
Wort), or vitamins and minerals from 2 weeks (for prescribed) or 1 week (for
non-prescribed) prior to the first administration of study drug or longer if the
medication has a long half-life. Occasional use of paracetamol/acetaminophen is
allowed for minor pains and headache.

12. Subjects currently receiving medications or herbal supplements known to be potent
inhibitors of CYP3A4 and potent inducers of CYP3A4 (from 2 weeks prior to the first
administration of study drug). All subjects must avoid concomitant use of any
medications, herbal supplements and/or ingestion of foods with known
inducer/inhibitory effects on CYP3A4.

13. Any intake of grapefruit, grapefruit juice, or other products containing grapefruit
within 14 days of the first administration of study drug.

14. Subjects who have used any investigational drug in any clinical trial within 60 days
of the screening visit.

15. Subjects who are vegans or have medical dietary restrictions.

16. Subjects who cannot communicate reliably with the Investigator.

17. Subjects who are unlikely to co-operate with the requirements of the study.