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Clinical Trials in the EU / 2025-525111-17-00
Ended Phase I/II

A Phase 1b/2a first-in-human, multicentre, randomized, double-blind, placebo-controlled study of multiple ascending dose (Part1) followed by an open-label extension (Part2) to assess the safety, tolerability, and pharmacokinetics of intrathecally administered S233107 in participants with spinocerebellar ataxia type 3

2025-525111-17-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
30/07/2026
Enrollment target
50
Sites
France, Denmark, Spain, Portugal

Condition studied

Spinocerebellar ataxia type 3

Investigational medicinal product(s)

S233107 Solution for injection 15 mg/mLS233107 Solution for injection 4 mg/mLPlacebo matching S233107

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Part 1 and 2: - Incidence and severity of AEs - Incidence of abnormalities in 12-lead ECG, clinical laboratory assessments in blood and CSF, vital signs, weight, and suicide risk.

Endpoint detail

Part 1 and 2: - Concentrations and derived PK parameters of S233107 in CSF and plasma, including but not limited to CSF Ctrough, plasma Cmax and plasma AUC0-tau.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-525111-17-00 on CTIS ↗ ← All trials in the EU