Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

NCT03225833 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-02-10

Study results available
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Summary

PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).

Conditions

Interventions

DRUG

WVE-120101

WVE-120101 is a stereopure antisense oligonucleotide (ASO)

DRUG

Placebo

0.9% Sodium Chloride

Sponsors & Collaborators

  • Wave Life Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Wave Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2021-05-11
Completion
2021-05-11

Countries

  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Poland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03225833 on ClinicalTrials.gov