NCT07536061 · Phase 1 · RECRUITING

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

This trial is testing SRP-1005, a new experimental drug, in people who have been genetically diagnosed with Huntington's disease. It is a Phase 1 study, meaning the primary goal is to learn whether the drug is safe in humans for the first time — it is not yet known whether it works. Participants receive either the drug or a placebo. Details beyond safety and early tolerability are limited so far.

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-06-04

View full record on ClinicalTrials.gov

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