insightt
Recruiting
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)
Randomized, double-blind, placebo-controlled study. This is a first-in-human, multi-center trial studying the effects of new drug SRP-1005 in participants with HD. It will look at the safety, tolerability , PK and PD and appropriate dosage.
The drug or placebo will be delivered by an injection under the skin . There will be three injections given once weekly over a 15-day period. They then enter a 24-week follow-up period.
It uses aspecial approach that binds to a protein called transferrin receptor1 (TfR1), helping the medicine cross the blood-brain barrier so it can reach the brain. It will aim to lower both the normal(HTT) and mutant(mHTT) allele.
- Primary outcomes is safety
- Secondary outcomes are drug concentration measurements –Blood(plasma): how much drug is circulating in the bloodstream. Urine: how much drug or drug-related material is being eliminated. CSF: whether the drug reaches the fluid surrounding the brain and spinal cord.
Phase: 1
Subtype: Interventional Therapeutic
Primary Purpose: Treatment
Primary Intervention: SRP-1005
Mode of Action: HTT Lowering, siRNA
Duration: 31 weeks
Ages Eligible
for Study:
21-70 years old
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- 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.
- 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.
