Status:
RECRUITING
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Huntington's Disease
Eligibility:
All Genders
25-70 years
Phase:
PHASE1
Brief 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
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 5 2028
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06585449
Start Date
October 14 2024
End Date
July 5 2028
Last Update
December 24 2025
Active Locations (19)
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1
Clinical Trial Site
Edmonton, Alberta, Canada, T6G 2B7
2
Clinical Trial Site
Vancouver, British Columbia, Canada, V6T 2B5
3
Clinical Trial Site
Ottawa, Ontario, Canada, K1Y4E9
4
Clinical Trial Site
Montreal, Quebec, Canada, H2W 1T8