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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

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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Farabursen (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Regulus Therapeutics

    • Most Recent Events

    • 13 Mar 2025 According to a Regulus Therapeutics media release, the company look forward to sharing topline data from all 26 subjects in cohort 4 in the coming weeks.
    • 29 Jan 2025 According to a Regulus Therapeutics media release, Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement on key components of a Phase 3 single pivotal trial for potential Accelerated Approval.
    • 29 Jan 2025 Interim results presented in the Regulus Therapeutics Media Release.

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