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

Last updated: May 1, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Huntington's Disease

Dyskinesias

Memory Loss

Treatment

Placebo

ALN-HTT02

Clinical Study ID

NCT06585449
ALN-HTT02-001
  • Ages 25-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose of ALN-HTT02.

Eligibility Criteria

Inclusion

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 <45 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

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 14, 2024
Estimated Completion Date:
July 05, 2028

Connect with a study center

  • Clinical Trial Site

    Edmonton,
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal,
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Ottowa,
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Vancouver,
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Bayern,
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Bochum,
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Venusberg,
    Germany

    Active - Recruiting

  • Clinical Trial Site

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    London,
    United Kingdom

    Active - Recruiting

  • Clinical Trial Site

    Oxford,
    United Kingdom

    Active - Recruiting

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