Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery

Inclusion Criteria

• Male or female subjects ≥18 years of age at Screening.
• Able and willing to comply with all study procedures.
• Stable kidney function per Investigator assessment and no known episodes of AKI during the preceding 4 weeks.
• Scheduled to undergo non-emergent coronary and/or valve surgery(ies) requiring cardiopulmonary bypass, including:
• CABG alone;
• Combined CABG surgery/repair of 1 or more cardiac valves;
• Cardiac valve(s) replacement or repair alone.
• Females and males of childbearing potential must agree to use 2 forms of contraception, with at least 1 being a barrier method, or abstain from sexual activity for 30 days following study drug administration.
• Male subjects must agree not to donate or sell sperm for 30 days following study drug administration.

Exclusion Criteria

• Presence of AKI (KDIGO criteria) at the time of Screening.
• Surgery to be performed without cardiopulmonary bypass.
• Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature 2X the upper limit of normal at time of Screening or Child Pugh Class C liver disease or higher.
• Any congenital coagulation disorder.
• Asplenia (anatomic or functional).
• History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-1.
• Known hypersensitivity or previous anaphylaxis to SnPP or any tin-based product.
• Serum ferritin >500 ng/mL or those who have received IV iron within 28 days of Screening.
• Pregnancy or lactation.
• Treatment with an investigational drug or participation in an interventional study within 30 days prior to administration of study drug.
• In the opinion of the Investigator, any disease processes or confounding variables that would inappropriately alter the outcome of the study.
• Inability to comply with the requirements of the study protocol.