NCT06585449 A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
| NCT ID | NCT06585449 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Huntington's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-10-14 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alnylam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06585449 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 70 Years, studying Huntington's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06585449 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06585449 currently recruiting?
Yes, NCT06585449 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.
Where is the NCT06585449 trial being conducted?
This trial is being conducted at Edmonton, Canada, Montreal, Canada, Ottawa, Canada, Vancouver, Canada and 11 additional locations.
Who is sponsoring the NCT06585449 clinical trial?
NCT06585449 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 66 participants.