A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

• 1. Male or female ADPKD patients, 18 to 70 years old
• 2. Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon either the MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented Mayo classification)
• 3. eGFR between 30 to 90 mL/min/1.73 m2
• 4. Body mass index (BMI) 18 to 35 kg/m2
• 5. Must understand and consent to the study procedures explained in the ICF and be willing and able to comply with the protocol
• 1. Administration of tolvaptan in the 28 days before randomization
• 2. Subject is mentally incapacitated or has significant emotional problems
• 3. Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements; or may pose a risk to the subject's safety
• 4. History or presence of alcoholism or drug abuse within the past 2 years prior to screening
• 5. Only one kidney or kidney transplant recipient
• 6. Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day or 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.