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: 26 Mar 2018

At a glance

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

    • 26 Mar 2018 According to an Alnylam Pharmaceuticals media release, based on the data from this study, European Medicines Agency (EMA) has granted PRIME Designation for accelerated assessment of Lumasiran.
    • 24 Mar 2018 Results describing development of PK/PD model and assessing relationship between Lumasiran dose, predicted liver concentrations and observed plasma glycolate levels presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 08 Feb 2018 According to an Alnylam Pharmaceuticals media release, new positive data from the Phase 1/2 study presented at the American Society of Nephrology Kidney Week 2017 Annual Meeting.
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