NCT04146285

A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.

Detailed description

This is a Phase 1, open-label, dose-escalation study in NMOSD patients in which subjects will receive BAT4406F injection via intravenous infusion. A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The overall objective is to assess the safety, tolerability, and pharmacokinetics of BAT4406F injection in NMOSD patients.

Conditions

• Neuromyelitis Optica Spectrum Disorders

Interventions

Type	Name	Description
DRUG	BAT4406F	Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-03-13
• Completion: 2023-12-25
• First posted: 2019-10-31
• Last updated: 2025-07-10

Locations

1 site across 1 country: China