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A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD

StatusRecruiting
PhasePhase 1/2
Started2023-02-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 14 sites
2025-08-20
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v3
Primary completion date2025-09-01→2028-04-01
Completion date2025-09-15→2028-10-15
Enrollment target65→68
Study sites15→14
Eligibility criteriarevised
[...] in the ATXN1 gene SCA3: ≥61 repeats in the ATXN3 gene HD: ≥3640 CAG repeats in the HTT gene. Please note there will be addi [...]
Study description+431 characters
[...] total duration of trial participation for each participant in Dose-level Cohorts 1-3 is up to approximately 4245 weeks, consisting of a screening period of up to 6 weeks, a 1314-week dosing period with the study drug VO659 being administered intrathecally four times, and a 2325-week post-dosing period. DuringThe total duration of trial participation for each participant in Dose-level Cohort 4 is up to approximately 58 weeks, consisting of a screening period of up to 7 weeks, a 26-week dosing period, and a 25-week post dosing period. The total duration of trial participation for each participa [...] [...]
2024-04-05
Study Status, Contacts/Locations v2
Study sites5→15
2023-08-21
Study Status, Contacts/Locations v1
Study sites1→5
2023-04-07
Original filing
The goal of this first-in-human clinical trial is to assess the safety and tolerability of four doses of a new study drug called VO659 in people with genetic disorders called spinocerebellar ataxia type 1, type 3 or Huntington's disease. Another aim is to determine the concentrations of the study drug in the cerebral spinal fluid and blood after single and multiple doses. Study drug will be administered by lumbar intrathecal bolus injections.
Trial Details
NCT Number NCT05822908
Lead Sponsor Vico Therapeutics B. V.
Conditions Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 3, Huntington Disease
Enrollment 68 participants
Start Date 2023-02-14
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-19