Status and phase
Conditions
Treatments
About
Primary Objective
• To assess the dose response relationship between RGLS4326 and ADPKD biomarkers
Secondary Objectives
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female ADPKD patients 18 to 70 years old
Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon prior MRI or CT Scan or MRI obtained during screening)
Estimated GFR at Screening between 30 to 90 mL/min/1.73 m^2 calculated by the investigator using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)
Body mass index (BMI) between 18 and 35 kg/m^2
If the patient has hypertension, the antihypertensive regimen must be stable for at least 28 days prior to randomization and the blood pressure adequately controlled prior to randomization
Female patients of childbearing potential must not be lactating and must have no plans to become pregnant during the course of the study through 28 days after the last dose of study drug. Female patients of childbearing potential who are heterosexual must agree to use one of the following methods of contraception considered to be highly effective (i.e., results in <1% failure rate when used consistently and correctly) from screening through 28 days after the last dose of study drug:
Female patient of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to the first dose of study drug:
Male patients must agree to use a condom during heterosexual intercourse and to not have unprotected sexual intercourse with a female who is pregnant or breastfeeding from screening through 28 days after the last dose of study drug; and must agree to refrain from sperm donation for at least 90 days after the last dose of study drug
Screening hematology and clinical chemistries must meet the following criteria:
Able to understand all study procedures in the informed consent form (ICF) and willing to comply with all aspects of the protocol
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
19 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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