RecruitingPhase 1

A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease

Canada, Germany66 participantsStarted 2024-10-14

Plain-language 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.

Who can participate

Age range25 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Has stage 2 or early Stage 3 Huntington's disease (HD), per the Huntington's Disease Integrated Staging System (HD-ISS) Exclusion Criteria * 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) Note: other protocol defined inclusion / exclusion criteria apply

What they're measuring

Frequency of Adverse Events (AEs) in the Double-blind Part of the Study

Timeframe: Up to 12 months

Frequency of AEs in the Open-label Part of the Study

Timeframe: Up to 12 months

Frequency of AEs in the OLE Part of the Study

Timeframe: Up to 36 months

Trial details

NCT IDNCT06585449

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-05

Contact for this trial

Alnylam Clinical Trial Information Line

1-877-ALNYLAM clinicaltrials@alnylam.com

View on ClinicalTrials.gov More Huntington's Disease trials