A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease (NCT07536061) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
New Zealand32 participantsStarted 2026-05-05
Plain-language summary
This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).
Who can participate
Age range21 Years – 70 Years
SexALL
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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.
What they're measuring
1
Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Timeframe: Baseline through Week 24
Trial details
NCT IDNCT07536061
SponsorSarepta Therapeutics, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-11-30
Contact for this trial
Sarepta Therapeutics Inc., For Clinical Trial Information, Select Option 4