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A phase I multiple ascending-dose study of RGLS-4326 in healthy volunteers

Trial Profile

A phase I multiple ascending-dose study of RGLS-4326 in healthy volunteers

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 18 Nov 2019

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At a glance

  • Drugs RGLS 4326 (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions
  • Sponsors Regulus Therapeutics
  • Most Recent Events

    • 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.
    • 23 Jul 2019 According to an Regulus Therapeutics media release, FDA has requested the final reports from the chronic toxicity studies in both mice and NHP and satisfactory related analyses to ensure subjects can be safely dosed. Additional data and analyses from new nonclinical studies are planned to be generated over the next several quarters which is required to support the resumption of the MAD study. Data to be generated from additional studies is expected to be completed in early 2020.
    • 23 Jul 2019 According to an Regulus Therapeutics media release, after review of the requested submission, FDA notified the company of additional nonclinical data requirements and placed the IND on a partial clinical hold.
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