A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02

The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group,
PK study in subjects with various severities of renal dysfunction and healthy volunteers.

Subjects will be categorized in 4 groups:

Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment
Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal
renal function

The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in
a parallel fashion. At this point, interim PK analyses will be performed and a safety
committee composed of Sponsor and Contract Research Organization (CRO) members will jointly
review the PK data before dosing the patients with severe renal disease (group 3). Control
subjects (group 4) will be recruited after the recruitment of groups 1 to 3.

Inclusion Criteria:

1. Male or female, non-smoker and/or light smoker

2. Have a diagnosis of renal impairment that has been stable, without any significant
change in overall disease status in the last 3 months prior to screening.

3. Have an estimated glomerular filtration rate (eGFR) expressed in mL/min/1.73 m2
(Modification of Diet in Renal Disease 4-variable [MDRD4] equation) at screening
within the range of:

1. Group 1 - Mild Group: 60 - 89 mL/min/1.73 m2;

2. Group 2 - Moderate Group: 30 - 59 mL/min/1.73 m2;

3. Group 3 - Severe Group: < 30 mL/min/1.73 m2 not requiring dialysis. eGFR results
that are deemed inconsistent with the usual stage of renal impairment may be
repeated. Subjects are categorized into severity group at screening. If the eGFR
scores change on Day-1 or other visit due to a non-clinically significant change
in clinical status or laboratory result, the subject keeps the original severity
group.

4. Subject may have stable treated medical illnesses and underlying diseases producing
the renal impairment such as diabetes, hypertension, or cardiovascular disease,
providing that, in the opinion of the PI, the disease is stable.

5. Have normal or non-clinically significant findings at physical examination, vital
signs and electrocardiogram (ECG) and normal limits or non-clinically significant
deviations in clinical laboratory evaluations at screening.

6. Other than renal impairment, have no other conditions which may significantly impact
study drug absorption or metabolism.

7. Stable medical regimen, deemed not to interact with study drug PK, for 14 days prior
to dosing, except for routine daily management of electrolytes (e.g. potassium),
acid-base, or other associated disorders expected in patients with renal impairment.

8. Females of childbearing potential who are sexually active with a non-sterile male
partner (sterile male partners are defined as men vasectomized since at least 6
months) must be willing to use acceptable contraceptive method throughout the study
and for 30 days after study drug administration.

9. Male subjects who are not vasectomized for at least 6 months, and who are sexually
active with a non-sterile female partner (sterile female partners include
post-menopausal females and surgically sterile females) must be willing to use
acceptable contraceptive method from dosing until at least 90 days after study drug
administration.

10. Male subjects (including men who have had vasectomy) with a pregnant partner must
agree to use a condom from dosing until at least 90 days after study drug
administration.

11. Male subjects must be willing not to donate sperm until 90 days following study drug
administration.

12. Able to understand and willing to sign the Informed Consent Form (ICF) and comply with
the study restrictions.

Exclusion Criteria:

1. Unstable renal function or acute exacerbation of renal disease within 14 days of study
drug administration, as indicated by recent history or worsening of clinical and/or
laboratory signs of renal impairment.

2. Has a functioning renal transplant.

3. Major illness or surgery within 4 weeks prior to dosing.

4. Clinically significant unstable medical condition or history of any illness that may
increase the risk associated with study participation or investigational drug
administration or may interfere with the interpretation of study results and would
make the subject inappropriate for entry into this study.

5. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at
screening.

6. History of allergic reactions, hypersensitivity or toxic reactions to aminoglycosides.

7. History of anaphylaxis.

8. Supine 12-lead ECG abnormalities at screening considered clinically significant.

9. Clinically significant vital sign abnormalities at screening.

10. History of significant drug or alcohol abuse within six months prior to screening.

11. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days (or 5 half-lives, whichever
is longer) prior to dosing, administration of a biological product in the context of a
clinical research study within 90 days prior to dosing, or concomitant participation
in an investigational study involving no drug or device administration.

12. Positive urine drug screen or alcohol test at screening.

13. Female subject with positive pregnancy test at screening.

14. Breast-feeding or pregnant subject within 6 months prior to study drug administration.

15. Use of any drugs known as strong inducer or inhibitor of hepatic drug metabolism
within 30 days prior to study drug administration.

16. Use of medication other than stable medications approved by the PI and topical
products without significant systemic absorption.

17. Use of prohibited medications as directed in the protocol.

18. Donation of plasma within 7 days prior to dosing. Donation or loss of blood within 30
days prior to the first dosing.

19. Any reason which, in the opinion of the PI, would prevent the subject from
participating in the study.

20. Inability to be venipunctured and/or tolerate catheter venous access.

21. Presence of mitochondrial mutation(s) making the subject susceptible to aminoglycoside
toxicity.

22. Presence of signs of dehydration, recent history of neuromuscular blockade or
clinically significant history of vestibular impairment.