At a glance
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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's Disease (SELECT-HD)
In Brief
A Phase 2 clinical trial evaluating SAD: 30mg WVE-003, SAD: 60mg WVE-003, and 4 other interventions for Huntington Disease. Completed, enrolled 47 participants across 23 sites in 10 countries.
Detailed Summary
This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of WVE-003 in adult patients with early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3.
Study Details
Timeline
Interventions
Single ascending dose of 30mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO)
Single ascending dose of 60mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO)
Single ascending dose of 90mg WVE-003, an allele-selective stereopure antisense oligonucleotide (ASO)
Single dose of placebo
Three doses of 30mg WVE-003 Q8WK an allele-selective stereopure, antisense oligonucleotide (ASO)
Three doses of placebo Q8WK