Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

Ki vehet részt

• Male/female subject aged ≥19 years inclusive at the time of informed consent
• Clinical diagnosis of type 2 diabetes and DKD
• 18.5 kg/m² < body mass index < 35 kg/m²
• Stable UACR values prior to screening visit
• UACR between 200 and 3000 mg/g
• Hemoglobin A1c ≤10% at Screening Visit
• Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication
• Subject who has been on stable anti-hyperglycemic prior to screening
• Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control
• Willing to be under dietary management for diabetes
• Willing to comply with all study procedures and availability for the duration of the study
• Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures

Ki nem vehet részt

• History of drug or alcohol abuse within 1 year prior to screening
• Administration of any investigational product
• Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months
• History of type 1 diabetes mellitus or gestational diabetes
• Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD
• History of renal transplant and/or plan to undergo a renal transplant during the study
• History of acute kidney injury or renal dialysis
• Subject with known or suspected hypersensitivity to any components of the APX-115 formulation
• History of any cardiovascular event or cardiovascular procedure planned during the clinical study
• Current or history of New York Heart Association class III or IV heart failure
• Known significant liver disease
• Subject with active urinary tract infection or has not fully recovered before randomization
• History of malignancy within 5 years prior to screening
• Positive hepatitis B surface antigen
• Clinically significant abnormal laboratory findings at screening
• Subject with uncontrolled blood pressure
• Subject taking immunosuppressant
• Clinically significant electrocardiogram (ECG) abnormalities
• Female subject who is pregnant or breastfeeding
• Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study
• Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status