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)

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)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jan 2018

At a glance

  • Drugs DCR PHXC (Primary)
  • Indications Primary hyperoxaluria
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Dicerna Pharmaceuticals
  • Most Recent Events

    • 07 Dec 2017 According to a Dicerna Pharmaceuticals media release, the company today announced the dosing of the first human in this trial and expects to dose the first patient in Group B (in patients with PH) in the first quarter of 2018.
    • 07 Dec 2017 Status changed from planning to recruiting, according to a Dicerna Pharmaceuticals media release.
    • 02 Nov 2017 According to a Dicerna Pharmaceuticals media release, this trial is planned to initate in first quarter of 2018 in UK and anticipates initial data in second half of 2018. Also, company plans to file an IND in the U.S. in the first quarter of 2018
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