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A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi-Center Study in Patients With Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR-PHXC Solution for Injection (Subcutaneous Use)

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Trial Profile

A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi-Center Study in Patients With Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR-PHXC Solution for Injection (Subcutaneous Use)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Nedosiran (Primary)
  • Indications Primary hyperoxaluria; Primary hyperoxaluria type 1
  • Focus Adverse reactions; First in man; Pharmacokinetics; Proof of concept
  • Acronyms PHYOX; PHYOX1
  • Sponsors Dicerna Pharmaceuticals

    • Most Recent Events

    • 01 Mar 2022 Results assessing safety, pharmacokinetics, pharmacodynamics, and exposure-response of subcutaneous nedosiran published in the Kidney International
    • 04 Jan 2021 According to a Dicerna Pharmaceuticals media release, data from PHYOX1, PHYOX2, PHYOX4, the ongoing PHYOX3 open-label extension study, and the PHYOX-OBX natural history study of PH3 participants, are expected to form the basis of the nedosiran New Drug Application (NDA) submission in the third quarter of 2021.
    • 06 Aug 2020 Interim results presented in the Dicerna Pharmaceuticals Media Release.

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