A Phase Ib/II first-in-human, multicentre, open-label, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of intrathecal S230815 in paediatric participants with KCNT1-related Developmental and Epileptic Encephalopathy

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513332-17-00

Acronym

CL1-230815-001

Enrollment

Registered

2025-08-04

Start date

2025-11-19

Completion date

Unknown

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KCNT1-related Developmental and Epileptic Encephalopathy

Brief summary

Incidence and severity of adverse events (AEs).

Detailed description

PK parameters of S230815 [CCI] Cmax, plasma Ctrough and plasma AUC0-τ [CCI]

Interventions

DRUGS230815 Solution for injection 10mg/ml

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (AEs).	—

Secondary

Measure	Time frame
PK parameters of S230815 [CCI] Cmax, plasma Ctrough and plasma AUC0-τ [CCI]	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026