Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1

Primary Hyperoxaluria Type 1 (PH1) Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hyperoxaluria, Primary
• Primary Hyperoxaluria Type 1 (PH1)

• NCT number: NCT02706886
• Study type: Interventional
• Source: Alnylam Pharmaceuticals
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 8, 2016
• Completion date: January 23, 2019