NCT07536061 A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
| NCT ID | NCT07536061 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sarepta Therapeutics, Inc. |
| Condition | Huntington's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 32 participants in total. It began in 2026-05-12 with a primary completion date of 2027-11-30.
⚠ 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
This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).
Eligibility Criteria
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.
Contact & Investigator
Sarepta Therapeutics Inc., For Clinical Trial Information, Select Option 4
✉ SareptAlly@sarepta.com📞 1-888-SAREPTA (1-888-727-3782)
Medical Director
STUDY DIRECTOR
Sarepta Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT07536061 clinical trial?
This trial is open to participants of all sexes, aged 21 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 NCT07536061 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 NCT07536061 currently recruiting?
Yes, NCT07536061 is actively recruiting participants. Contact the research team at SareptAlly@sarepta.com for enrollment information.
Where is the NCT07536061 trial being conducted?
This trial is being conducted at Auckland, New Zealand, Christchurch, New Zealand.
Who is sponsoring the NCT07536061 clinical trial?
NCT07536061 is sponsored by Sarepta Therapeutics, Inc.. The principal investigator is Medical Director at Sarepta Therapeutics, Inc.. The trial plans to enroll 32 participants.