Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
Status:
Completed
Trial end date:
2019-01-23
Target enrollment:
Participant gender:
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.