A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease

Sponsor
Sarepta Therapeutics, Inc.
Study ID
NCT07536061
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SRP-1005 — DRUG
    Subcutaneous injection
  • Placebo — DRUG
    Subcutaneous injection

Study Details

This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).

Key Dates

Start date
May 12, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: SRP-1005 Dose 1
    Participants will receive SRP-1005 or placebo.
  • Experimental: Cohort 2: SRP-1005 Dose 2
    Participants will receive SRP-1005 or placebo.
  • Experimental: Cohort 3: SRP-1005 Dose 3
    Participants will receive SRP-1005 or placebo.
  • Experimental: Cohort 4: SRP-1005 Dose 4
    Participants will receive SRP-1005 or placebo.

Primary Outcome Measure

Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) [ Time Frame: Baseline through Week 24 ]

Central Contacts

  • Sarepta Therapeutics Inc., For Clinical Trial Information, Select Option 4
    1-888-SAREPTA (1-888-727-3782)
    [email protected]

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