A Phase 1/2, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered ALN-GO1 in Healthy Adult Subjects, and Patients With Primary Hyperoxaluria Type 1

Trial Profile

A Phase 1/2, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered ALN-GO1 in Healthy Adult Subjects, and Patients With Primary Hyperoxaluria Type 1

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Lumasiran (Primary)
  • Indications Primary hyperoxaluria
  • Focus Adverse reactions; First in man
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 22 Nov 2017 Planned primary completion date changed from 1 Feb 2019 to 1 Jan 2020.
    • 03 Nov 2017 According to an Alnylam Pharmaceuticals media release, Part A, now complete, was a single-dose study that enrolled 32 healthy adult volunteers in four single ascending dose cohorts (N=8 per cohort, randomized 3:1 drug:placebo), with subjects receiving lumasiran at dose ranges of 0.3 to 6 mg/kg.
    • 03 Nov 2017 Initial data from part B of this trial presented in an Alnylam Pharmaceuticals Media Release.
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