A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease
NCT04536688 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2021-12-15
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
Conditions
- Polycystic Kidney Disease, Autosomal Dominant
Interventions
- DRUG
-
RGLS4326
Solution for subcutaneous injection
Sponsors & Collaborators
-
Regulus Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Karl Cremer, PharmD · Regulus Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-13
- Primary Completion
- 2021-11-12
- Completion
- 2021-11-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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