A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose and an Open-Label Fixed-Dose Study in Patients With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Primary Objectives * To assess the safety and tolerability of RGLS8429 * To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives * To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) * To characterize the pharmacokinetic (PK) properties of RGLS8429 * To assess the impact of RGLS8429 on renal function
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Male or female ADPKD patients, 18 to 70 years old
• 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)
• eGFR between 30 to 90 mL/min/1.73 m2
• Body mass index (BMI) 18 to 35 kg/m2
• Must understand and consent to the study procedures explained in the ICF and be willing and able to comply with the protocol
Locations
United States
Arizona
Centricity Research Phoenix Multispecialty
TERMINATED
Mesa
California
Amicis Research Center
WITHDRAWN
Beverly Hills
National Institute of Clinical Research, Inc.
WITHDRAWN
Garden Grove
Amicis Research Center
WITHDRAWN
Granada Hills
California Institute of Renal Research
WITHDRAWN
La Mesa
Academic Medical Research Institute
RECRUITING
Los Angeles
Valiance Clinical Research
WITHDRAWN
S. Gate
Connecticut
Yale Nephrology Outpatient Clinic
RECRUITING
New Haven
Florida
Horizon Research Group, LLC
WITHDRAWN
Coral Gables
Mayo Clinic - Florida
RECRUITING
Jacksonville
Elixia
COMPLETED
Orlando
Georgia
Southeastern Clinical Research Institute, LLC
RECRUITING
Augusta
Iowa
University of Iowa
RECRUITING
Iowa City
Idaho
CARE Institute
RECRUITING
Boise
CARE Institute
RECRUITING
Chubbuck
The Idaho Kidney Institute
RECRUITING
Idaho Falls
Illinois
Research by Design, LLC
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Kansas
University of Kansas Medical Center Jared Grantham Kidney Institute
RECRUITING
Kansas City
Witchita Nephrology Group, PA
RECRUITING
Wichita
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Maryland
University of Maryland School of Medicine, Nephrology
RECRUITING
Baltimore
Michigan
St. Clair Nephrology Research
RECRUITING
Roseville
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
Nevada
Nevada Kidney Disease and Hypertension Centers
WITHDRAWN
Las Vegas
Pennsylvania
Northeast Clinical Research Center
RECRUITING
Bethlehem
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Washington
Swedish Center for Comprehensive Care
RECRUITING
Seattle
Contact Information
Primary
Kristen Gillotti
kgillotti@regulusrx.com
858-202-6300
Time Frame
Start Date: 2022-10-06
Estimated Completion Date: 2025-06
Participants
Target number of participants: 70
Treatments
Experimental: RGLS8429
The randomized,double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total).~* Cohort 1: first dose level of RGLS8429 or placebo~* Cohort 2: second dose level of RGLS8429 or placebo~* Cohort 3: third dose level of RGLS8429 or placebo
Experimental: Placebo
The randomized double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total).~* Cohort 1: first dose level of RGLS8429 or placebo~* Cohort 2: second dose level of RGLS8429 or placebo~* Cohort 3: third dose level of RGLS8429 or placebo
Experimental: Open Label Fixed Dose RGLS8429
The open-label fixed dose part of the study (Part B and Cohort 4) will consist of a single cohort of up to 30 subjects each receiving 300 mg RGLS8429.
Related Therapeutic Areas
Sponsors
Leads: Regulus Therapeutics Inc.