A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects

Inclusion criteria

• Willing and able to give full written informed consent for participation in the study.
• Healthy male or female subject aged 18-45 years inclusive.
• Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
• Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
• With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
• Male subjects and applicable female subjects must agree to use effective contraceptive methods to prevent drug exposure of a partner and pregnancy.

Exclusion criteria

• History of allergy to iohexol or other contrast media, to iodine or to shellfish.
• History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
• Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
• Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
• Subjects with poor venous access.
• Subjects who have smoked cigarettes (including vapour cigarettes), cigars, and/or used nicotine-containing products within 3 months prior to their screening visit.
• Positive screen for a drug of abuse or alcohol at screening or prior to administration of the IMP.
• Subjects who have not abstained from caffeine-containing beverages or products from at least 48 hours prior to screening.
• An abnormal diet within the 30 days prior to the first study drug dose.
• Any use of protein powders, xanthine and/or taurine containing energy drinks within 48 hours prior to screening.
• Blood donation (or corresponding blood loss) during the three months prior to screening.
• Employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
• Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.