Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

Inclusion criteria

• Age 18-80 years, inclusive
• Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
• First morning urinary ACR >0.200 g/g
• Receiving stable doses of ACEi and/or ARB therapy prior to Screening
• Estimated glomerular filtration rate of ≥20 and <90 mL/min/1.73 m2
• Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
• Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization

Exclusion criteria

• Female subjects who are pregnant or breastfeeding
• Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
• Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
• Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
• Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
• History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
• History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
• Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal
• Hemoglobin <10 g/dL
• Positive for HIV (IgG) antibody