NCT04536688

A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Regulus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Polycystic Kidney Disease, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	RGLS4326	Solution for subcutaneous injection

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-11-12
• Completion: 2021-11-12
• First posted: 2020-09-03
• Last updated: 2021-12-15

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study