Recruiting NCT07536061
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SRP-1005, Placebo.
- Who it may be relevant to
- Registry conditions: Huntington's Disease. Basic parameters: 21 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Effect of SRP-1005 in Subjects With Huntington's Disease (INSIGHTT)
Overview
This is a first-in-human, multi-center trial studying the effects of SRP-1005 in participants with Huntington's disease (HD).
Interventions
- Drug SRP-1005
Subcutaneous injection - Drug Placebo
Subcutaneous injection
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Plasma Concentration of SRP-1005 [Time frame: Baseline through Day 17]
- Urine Concentration of SRP-1005 [Time frame: Baseline through Day 17]
- Cerebrospinal Fluid Concentration of SRP-1005 [Time frame: Baseline through Week 24]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
New Zealand · 2 centers
- Pacific Clinical Research Network - Auckland (PCRN Auckland) — Auckland
- New Zealand Brain Research Institute — Christchurch
Identifiers
NCT: NCT07536061 · SRP-1005-101