RecruitingPhase 1NCT06585449
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
A Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered Single Ascending Doses of ALN-HTT02 in Adult Patients With Huntington's Disease
Sponsor
Alnylam Pharmaceuticals
Enrollment
66 participants
Start Date
Oct 14, 2024
Study Type
INTERVENTIONAL
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.
Eligibility
Min Age: 25 YearsMax Age: 70 Years
Inclusion Criteria1
- Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS)
Exclusion Criteria5
- Has significant structural or degenerative neurologic disease other than Huntington's Disease (HD) at screening
- Has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies
- Has alanine aminotransferase or aspartate aminotransferase >2× upper limit of normal (ULN)
- Has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m\^2 at screening
- Has received an investigational agent within the last 1 year or 5 half-lives (if known)
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Interventions
DRUGALN-HTT02
ALN-HTT02 will be administered intrathecally
DRUGPlacebo
Placebo will be administered intrathecally
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06585449