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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History