A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

Inclusion Criteria

• Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
• Subject will need visualization of the ureter(s).
• Female subject is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
• Female subject must agree not to breastfeed starting at screening and throughout the study period.
• Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
• Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
• Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
• Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
• Subject agrees not to participate in another interventional study while participating in the present study.
• Subjects enrolled after optimal dose determination:

Subject has any of the following values at screening:

• Body mass index > 25
• Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.
• Subject has any of the following screening laboratory values:
• Hemoglobin ≤ 9 g/dL
• Absolute neutrophil count ≤ 1500/µL
• Platelet count ≤ 100000/µL
• eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
• Serum bilirubin ≥ 2 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
• Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
• Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
• Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
• Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
• Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.