Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

Inclusion Criteria:

- Male (who are surgically sterile or agree to practice barrier contraception
throughout their participation in the study) or Female (using oral or double barrier
contraceptive if sexually active, surgically sterile or post-menopausal confirmed by
follicle stimulation hormone test);

- Willing to give written informed consent

- 18 to 55 years of age at time of consent

- Body Mass Index of 18-30 kg/m2

- Non-smoker (for at least 6 months prior to screening) and willing to abstain from
smoking during the course of the study

- Good general health as determined by medical history, physical examination, 12-lead
electrocardiograms and clinical laboratory tests (including normal renal function and
high frequency audiometry)

- Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24
hours prior to and 72 hours after dosing.

- Japanese subjects must be first generation Japanese (4 grandparents, biologic parents
and subject born in Japan)

Exclusion Criteria:

- Uncontrolled, clinically significant disease which in the opinion of the Principal
Investigator or Medical Monitor would place the subject at risk through study
participation or would confound the assessment of the safety of ME1100 inhalation
solution

- Evidence of current or history of respiratory disease, including asthma, emphysema,
chronic bronchitis, or cystic fibrosis

- History or current symptom(s) of respiratory tract inflammation within 30 days of
Visit 2

- History of hearing, balance or ear disorder or surgery or injury to the ears, or with
genetic mutation (>5.0% heteroplasmy) suggestive of increased risk of hearing loss
(MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for
mitochondrial transfer RNA serine 1)

- History of parent, sibling or parental sibling reporting hearing loss before age 65
years

- History of malignancy

- History of clinically significant alcohol or drug abuse

- History within last 6 months or current use of any tobacco product including
e-cigarettes

- Positive drug screen for drugs of abuse

- Positive test for HIV, Hepatitis B or Hepatitis C

- Use of any prescription or over-the-counter medications (except oral or hormonal
contraceptives), herbal supplements, or vitamins within 14 days of Visit 2

- Known hypersensitivity to any aminoglycoside or bacitracin antibiotic

- Female of childbearing potential with a positive urine pregnancy test, or currently
breast feeding.

- Inability to perform reproducible spirometry in accordance with American Thoracic
Society (ATS) guidelines

- Abnormal Forced Expiratory Volume in the First Second (FEV1), Forced Vital Capacity
(FVC), or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)

- FEV1 variability > 10% between Visit 1 and Visit 2 (prior to dosing)

- Significant blood donation (or testing) in previous 8 weeks before screening.

- Use of any Investigational Product in previous 30 days or 5 half-lives, whichever is
longer, preceding start of screening.