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

Inclusion Criteria

• Male or female, non-smoker and/or light smoker
• 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.
• 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:
• Group 1 - Mild Group: 60 - 89 mL/min/1.73 m2;
• Group 2 - Moderate Group: 30 - 59 mL/min/1.73 m2;
• 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.
• 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.
• 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.
• Other than renal impairment, have no other conditions which may significantly impact study drug absorption or metabolism.
• 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.
• 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.
• 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.
• 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.
• Male subjects must be willing not to donate sperm until 90 days following study drug administration.
• Able to understand and willing to sign the Informed Consent Form (ICF) and comply with the study restrictions.

Exclusion Criteria

• 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.
• Has a functioning renal transplant.
• Major illness or surgery within 4 weeks prior to dosing.
• 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.
• Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
• History of allergic reactions, hypersensitivity or toxic reactions to aminoglycosides.
• History of anaphylaxis.
• Supine 12-lead ECG abnormalities at screening considered clinically significant.
• Clinically significant vital sign abnormalities at screening.
• History of significant drug or alcohol abuse within six months prior to screening.
• Participation in a clinical research study involving the administration of an investigational or market