A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
NCT04146285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-07-10
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.
Conditions
- Neuromyelitis Optica Spectrum Disorders
Interventions
- DRUG
-
BAT4406F
Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Xiangjun Chen · Huashan Hospital
-
Jing Zhang · Huashan Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2023-03-13
- Completion
- 2023-12-25
Countries
- China
Study Locations
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