SER150 vs Placebo in Diabetic Kidney Disease

Exclusion Criteria

• •Acute myocardial infarction within the last 3 months
• •Stroke within the last 3 months
• •Any major surgery in the last 3 months that in the opinion of the Investigator poses an increased bleeding risk.
• •ACR ≤ 200 mg/g creatinine
• •Urinary bladder infections within the last 3 months (all other urinary tract infections and vulvovaginitis are excluded)
• •Recent history (within the last 6 months) or ongoing liver disease, including viral infections
• •Participants with HIV
• •Participants with known specific renal diseases different from DKD
• •Any bleeding disorder or acute blood coagulation defect
• •A history of gastric ulcers or any other organic lesion susceptible to bleeding
• •Participant has had a confirmed COVID-19 infection by appropriate laboratory test (PCR or Rapid Antigen Test) within the last 4 weeks prior to screening or on admission
• •Participant who had severe course of COVID-19
• •Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period that, in the opinion of the Investigator, may compromise the safety of the participant in the study, reduce the participant's ability to participate in the study, or interfere with evaluation of the study drug
• •Change in antidiabetic treatment during last 3 months
• •Chronic treatment with nonsteroidal anti-inflammatory drugs or other anti-inflammatory compounds during the last month
• •Treatment with anticoagulant drugs
• •Participation in another clinical trial of an investigational small molecule, antibody (or medical advice) within 30 days (or 5 half-lives of the drug, whichever is longer \[if known\]) prior to the start of IP administration on Day 2 (or within 6 months prior to the start of IP administration on Day 1 if the investigational drug was a biologic).
• •Alanine aminotransferase or aspartate aminotransferase values exceeding 5 x upper limit of normal (ULN)
• •Alkaline phosphatase and/or total bilirubin values exceeding 1.5 x ULN
• •HbA1c \> 10%
• •eGFRcrea ≥75 mL/minute/1.73 m\^2 and ≤ 15 mL/minute/1.73 m\^2
• •Allergy to the active substance or any of the excipients of the drug product
• •Pregnant or lactating women