Clinical Trials in the UK / NCT07536061
Recruiting
Phase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
NCT07536061 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Huntington's Disease
Investigational drug(s) / intervention(s)
SRP-1005Placebo
SRP-1005: Subcutaneous injection
Placebo: Subcutaneous injection
Study summary
This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).
Eligibility
Key Inclusion Criteria:
* Genetically confirmed diagnosis of huntingtin (HTT) cytosine-adenine-guanine repeat length ≥40.
* Participant has HD Integrated Staging System (HD-ISS) Stage 2 or Mild Stage 3. At screening, the participant must be classified with the Enroll-HD HD-ISS Modified Calculator as either Stage 2 or Mild Stage 3.
* Participants who are of childbearing potential, or with partners of childbearing potential, who are sexually active must agree to use a highly effective method of contraception throughout study participation, and for at least 90 days following the end of study.
Key Exclusion Criteria:
* Any condition that would compromise the safety or feasibility of lumbar puncture or magnetic resonance imaging (MRI).
* Presence of other significant neurological or systemic illnesses.
* Current, chronic or active human immunodeficiency virus, hepatitis B/C.
* Recent use of investigational agents or HTT-lowering therapies.
* Uncontrolled psychiatric illness or substance use disorders.
* Pregnancy or lactation.
Note: Other inclusion/exclusion criteria apply.
Primary outcome measure(s)
- Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) — Baseline through Week 24
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Westmead Hospital | Westmead | New South Wales | Recruiting |
| Royal Melbourne Hospital | Parkville | Victoria | Recruiting |
| New Zealand Brain Research Institute | Christchurch | New Zealand | Recruiting |
| Siloah AG | Gümligen | Canton of Bern | Recruiting |
| University Hospital of Wales | Cardiff | United Kingdom | Recruiting |
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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 NCT07536061 on ClinicalTrials.gov ↗ ← All trials in the UK