A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric Participants With KCNT1-related Epilepsy

Conditions

• KCNT1-Related Epilepsy

Eligibility Criteria

Sex

ALL

Age

1 Month - 21 Years

Healthy Volunteers

Not accepted

Interventions

• ABS-1230 — DRUG
  Once daily
• Placebo — DRUG
  Once daily

Study Details

This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy

Key Dates

Start date

May 18, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ABS-1230 (Part 1)
• Experimental: ABS-1230 (Part 2)
• Experimental: Placebo (Part 2)
• Experimental: ABS-1230 (Part 3)

Primary Outcome Measure

Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) [ Time Frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) ]

Central Contacts

• Medical Director Actio Biosciences, Inc.
  +1 (858) 682-4042
  [email protected]

Locations (1)

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