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Clinical Trials in the UK / NCT06585449
Recruiting Phase 1

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

NCT06585449 · tracked via the Priya Life Science UK tracker
Sponsor
Alnylam Pharmaceuticals
Phase
Phase 1
Started
2024-10-14
Last updated
2026-10-15

Condition(s) studied

Huntington's Disease

Investigational drug(s) / intervention(s)

ALN-HTT02Placebo

ALN-HTT02: ALN-HTT02 will be administered intrathecally

Placebo: Placebo will be administered intrathecally

Study 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

Sex
ALL
Min age
25 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Frequency of Adverse Events (AEs) in the Double-blind Part of the Study — Up to 12 months
  • Frequency of AEs in the Open-label Part of the Study — Up to 12 months
  • Frequency of AEs in the OLE Part of the Study — Up to 36 months

Trial sites (19)

FacilityCityRegionStatus
Clinical Trial Site Edmonton Canada Recruiting
Clinical Trial Site Montreal Canada Recruiting
Clinical Trial Site Ottawa Canada Recruiting
Clinical Trial Site Vancouver Canada Recruiting
Clinical Trial Site Berlin Germany Recruiting
Clinical Trial Site Bochum Germany Recruiting
Clinical Trial Site Bonn Germany Recruiting
Clinical Trial Site Dresden Germany Recruiting
Clinical Trial Site Münster Germany Recruiting
Clinical Trial Site Taufkirchen Germany Recruiting
Clinical Trial Site Ulm Germany Recruiting
Clinical Trial Site Birmingham United Kingdom Recruiting
Clinical Trial Site Cambridge United Kingdom Recruiting
Clinical Trial Site Cardiff United Kingdom Recruiting
Clinical Trial Site Glasgow United Kingdom Recruiting
Clinical Trial Site Greater Manchester United Kingdom Recruiting
Clinical Trial Site London United Kingdom Recruiting
Clinical Trial Site Oxford United Kingdom Recruiting
Clinical Trial Site Plymouth United Kingdom Recruiting

More Alnylam Pharmaceuticals trials in the UK

A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy Enrolling by invitation
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease Recruiting
A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy Active, not recruiting
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP) Recruiting
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD Recruiting

Other trials for the same condition

A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585449 on ClinicalTrials.gov ↗ ← All trials in the UK