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Phase I randomized, double-blind, placebo-controlled, single ascending dose study of RGLS4326 in healthy volunteers

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Trial Profile

Phase I randomized, double-blind, placebo-controlled, single ascending dose study of RGLS4326 in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Feb 2021

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At a glance

  • Drugs RGLS 4326 (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 10 Feb 2021 According to a Regulus Therapeutics media release, the Company will use information from the first cohort of the Phase 1b in its plan to address the second set of requirements outlined in the Partial Clinical Hold letter to support studies of extended duration. Regulus plans to discuss its approach to addressing the remaining Partial Clinical Hold requirements with FDA in mid-2021.
    • 15 Oct 2020 According to a Regulus Therapeutics media release, the company plans to use data from the first cohort of phase 1b study, together with data from multiple ascending dose and single ascending dose studies in healthy volunteers as well as the recently completed nonclinical studies, to obtain feedback from the U.S. Food & Drug Administration(FDA) on the acceptability of the company's approach to addressing the second set of FDA requirements to support studies of extended duration in patients.
    • 18 Nov 2019 According to an Regulus Therapeutics media release, the company will present an update on RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and the company's recent submission to FDA in response to the partial clinical hold at the Stifel Healthcare Conference.
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