Polycystic Kidney Disease, Autosomal Dominant Clinical Trial
Official title:
A Phase 1b, Multicenter, Open-Label, Adaptive Design Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RGLS4326 Administered Via SC Injection to Patients With Autosomal Dominant Polycystic Kidney Disease
Primary Objective • To assess the dose response relationship between RGLS4326 and ADPKD biomarkers Secondary Objectives - To characterize the pharmacokinetic (PK) properties of RGLS4326 in plasma and urine - To assess the safety and tolerability of RGLS4326
This is a Phase 1b, open-label, adaptive design dose-ranging study to evaluate ADPKD biomarkers, PK, safety, tolerability, and pharmacodynamics (PD) of RGLS4326 administered via SC injection to patients with ADPKD. The goal is to assess the dose response relationship between RGLS4326 and ADPKD biomarkers. The study will consist of three sequential cohorts with approximately 18 to 27 subjects total. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00428948 -
Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD
|
Phase 3 |