Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI

Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Male or female, of any race or ethnicity, 18 years of age or older, inclusive, on theday of informed consent. Racial and ethnic minorities should be included in the studypopulation to the greatest extent possible.
3. Diagnosed with coronary artery disease.
4. Planned to undergo coronary angiography within 4 weeks of being consented.
5. Risk of CKD evidenced by 30 mL/min/1.73m2 ≤ eGFR (Glomerular filtration rate) < 90mL/min/1.73 m2 confirmed by local or central laboratory.
6. Women of childbearing potential or males willing and able to use at least oneprotocol-specified method of contraception for the duration of their enrolment.
7. Subject is aware of the investigational nature of this study and willing to complywith protocol treatments, blood tests, and other evaluations listed in the ICF.

Exclusion Criteria:

1. Females who are pregnant or who are planning to become pregnant before the end ofplanned enrolment or who are breastfeeding.
2. Subjects who are not expected to go through PCI at the discretion of investigator orcardiologist
3. Subjects who have a history of hypersensitivity to contrast media or who cannot beadministered contrast media according to investigator's discretion
4. Acute myocardial infarction within 1 month prior to Screening
5. ESRD confirmed by eGFR < 15 mL/min/1.73 m2 at Screening.
6. Clinically significant heart disease as determined by the Investigator within 2 monthsprior to Screening including but not limited to any of following; cardiogenic shock,treatment requiring intra-aortic balloon pump (IABP) support, treatment with extracorporeal membrane oxygenation (ECMO), or NYHA class IV heart failure.
7. Uncontrolled treated/untreated hypertension (defined as systolic blood pressure > 180mmHg and/or diastolic blood pressure > 100 mmHg, mean of measured 2 times at Screeningwill be permitted).
8. Known or suspected hypersensitivity to any component of the APX-115 formulation.
9. History of acute kidney injury or renal dialysis within 1 month prior to Screeningand/or plan to undergo a renal dialysis during enrolment.
10. Clinically apparent liver disease as determined by the Investigator (e.g., jaundice,cholestasis, hepatic synthetic impairment, or active hepatitis) or moderate or severehepatic impairment as determined by Child-Pugh score (Class B or C) at Screening.
11. Impaired liver function, defined as alanine aminotransferase (ALT) ≥ 2.5 times UNL orTotal bilirubin >1.5 × ULN, unless the subject has known Gilbert's syndrome.
12. Any sign or symptom of acute or chronic infection at Screening.
13. Receipt of any investigational drug within 4 weeks prior to Screening.
14. Confirmed or suspected abuse of alcohol or controlled substances within 1 year priorto Screening.
15. Clinically significant hematology abnormalities; hemoglobin <9 g/dL for females or <11g/dL for males, absolute neutrophil count <1500/mm3, platelet count <100 × 109/L) atScreening. If any parameter is below the specified threshold, one hematology retestanalyzed at the central or local laboratory within a week prior to randomization ispermitted with the result of the last sample being conclusive.
16. Any other clinically significant medical condition or laboratory abnormality asdetermined by the Investigator that might jeopardize the safety of the subject, impairsubject compliance, or impede safety/efficacy observations during enrolment.
17. Mental incapacity, unwillingness, or language barrier precluding adequateunderstanding or cooperation with protocol requirements
18. Use of CYP1A2, CYP2B6 and CYP3A4 substrates or UGT inhibitors and inducers or OAT3substrates prior to enrollment or concurrently. It will be only accepted to beeligible to screening if the subjects' concomitant medications will be reviewed andapproved by the medical monitor and/or sponsor prior to the initial study dose