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Clinical trialNCT02706886CompletedPhase 1/PHASE2Interventional

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

SponsorAlnylam PharmaceuticalsEnrollment52Primary Hyperoxaluria Type 1 (PH1)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France
  • Clinical Trial Site

    Bordeaux, France

  • Clinical Trial Site

    Lyon, France

  • Clinical Trial Site

    Paris, France

Germany
  • Clinical Trial Site

    Bonn, Germany

Israel
  • Clinical Trial Site

    Haifa, Israel

  • Clinical Trial Site

    Jerusalem, Israel

Netherlands
  • Clinical Trial Site

    Amsterdam, Netherlands

United Kingdom
  • Clinical Trial Site

    Birmingham, United Kingdom

  • Clinical Trial Site

    London, United Kingdom

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
8 Mar 2016
Primary completion
23 Jan 2019
Completion
23 Jan 2019
Last update posted
30 Jan 2020
Registered enrollment
52
Registry id
NCT02706886

Cross-registrations

EU-CTR / CTIS (EudraCT)2015-004407-23

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.