NCT07536061RecruitingPhase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Effect of SRP-1005 in Subjects With Huntington's Disease (INSIGHTT)
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 10 Apr 2026
- Start date
- 12 May 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Diseases
- Huntington's disease
- NCT number
- NCT07536061
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 12 May 2026 to the primary completion date, 30 Nov 2027
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of investigational agents or HTT-lowering therapies.
Other illness
- 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.
- Uncontrolled psychiatric illness or substance use disorders.
Other
- Pregnancy or lactation.
- Note: Other inclusion/exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 21 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Siloah AG Coordinator of this site? Confirm its status | Gümligen | Switzerland | Recruiting |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| New Zealand Brain Research Institute Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.