What is SRP-1005 studying for Huntington's disease?

SRP-1005 is being studied to understand its effects in people with Huntington's disease. Researchers want to evaluate its safety and how it behaves in the body compared to a placebo. This trial is sponsored by Sarepta Therapeutics, Inc.

Who may be eligible for this Huntington's disease clinical trial?

Adults aged 21 to 70 years with a genetically confirmed diagnosis of Huntington's disease at specific disease stages may be eligible. Both men and women can participate, but pregnancy and certain infections exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this Huntington's disease clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 21Years - 70Years

All Genders

ID07536061

Study of SRP-1005 Drug Given by Injection for Adults With Huntingtons Disease in Early to Mild Stages

Led by Sarepta Therapeutics, Inc. · Updated on 2026-06-04

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a first-in-human, multi-center clinical trial to study the effects of SRP-1005 in people with Huntingtons disease HD. The trial is designed to evaluate the safety and impact of SRP-1005, a drug given by subcutaneous injection, compared to a placebo. The study includes adult participants aged 21 to 70 years who have a genetically confirmed diagnosis of HD and are at specific disease stages. Participants will be randomly assigned to one of four groups receiving different doses of SRP-1005 or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. The treatment period includes dose escalation and monitoring to assess the drugs presence in plasma, urine, and cerebrospinal fluid over several weeks. During the study, participants will be monitored for side effects and adverse events from baseline through 24 weeks. Researchers will collect blood, urine, and cerebrospinal fluid samples to measure drug levels and safety. Participants must agree to use effective contraception if applicable, and the study excludes those with certain infections, other neurological illnesses, or conditions that prevent safe lumbar puncture or MRI. The total participation lasts at least 24 weeks with ongoing safety assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Genetically confirmed diagnosis of huntingtin (HTT) cytosine-adenine-guanine repeat length ≥40
Classified as Huntington's disease Integrated Staging System (HD-ISS) Stage 2 or Mild Stage 3 at screening
Age between 21 and 70 years
If of childbearing potential or with partners of childbearing potential and sexually active, agrees to use a highly effective contraception method during the study and for at least 90 days after

You will not qualify if you...

Any condition that makes lumbar puncture or MRI unsafe or not feasible
Presence of other significant neurological or systemic illnesses
Current, chronic, or active HIV, hepatitis B, or hepatitis C infection
Recent use of investigational agents or huntingtin-lowering therapies
Uncontrolled psychiatric illness or substance use disorders
Pregnancy or breastfeeding
Other unspecified exclusion criteria as noted by the study

Research Team

Sarepta Therapeutics Inc., For Clinical Trial Information, Select Option 4

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