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Not yet recruiting Phase 1 NCT07536061

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

Phase 1 – testing safety in a small group of people
Conditions: Huntington's Disease

Sponsor: Sarepta Therapeutics, Inc.

trial.available_in: БГ
Overview
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
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.
Locations 1
New Zealand (1)
Pacific Clinical Research Network - Auckland (PCRN Auckland)
Auckland
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
21 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
05.05.2026
Completion date
30.11.2027
Registry ID
NCT07536061
Source
anzctr
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