A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523939-18-00

Enrollment

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-04

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

Conditions

Amyotrofic Lateral Sclerosis (ALS)

Brief summary

Phase Ib: Number of treatment emergent adverse events (TEAEs) and number of serious adverse events (SAEs)., Phase II: TEAEs, and changes in vital signs, clinical laboratory tests, and 12-lead ECGs., Open label Extention: TEAEs, and changes in vital signs, clinical laboratory tests, and 12-lead ECGs.

Interventions

DRUGPlacebo capsules for NB 4746

DRUGNB-4746

DRUGRiluzole

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase Ib: Number of treatment emergent adverse events (TEAEs) and number of serious adverse events (SAEs)., Phase II: TEAEs, and changes in vital signs, clinical laboratory tests, and 12-lead ECGs., Open label Extention: TEAEs, and changes in vital signs, clinical laboratory tests, and 12-lead ECGs.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 5, 2026