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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuromyelitis Optica Spectrum Disorders

Intervention / Treatment
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* Drug: BAT4406F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Compliance with the NMOSD diagnostic criteria developed by the 2015 International NMO Diagnostic Team (IPND); 18-65 years old , male or female; At least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening; Discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline; EDSS score ≤ 6; Men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion; Agree to participate in the trial and sign the informed consent in writing. Exclusion Criteria: Any monoclonal antibody treatment was used within 6 months prior to dosing; Having been treated with anti-CD20 monoclonal antibody; Live vaccine received within 4 weeks before screening; Having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer); A history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs; Abnormal liver function, kidney function and bone marrow reserve; HIV-positive history or HIV-positive at screening; hepatitis B and/or hepatitis C history or hepatitis B surface antigen-positive at screening; or hepatitis C virus (HCV) antibody positive; treponema pallidum antibody positive when enrolled; History of infections that investigators have identified as unsuitable for testing; Patients with a clear history of heart disease ; Have a history of mental disorders; Pregnant or lactating women, and female subjects who have a positive pregnancy test at screening; None of the investigators or their relatives participating in the study could be enrolled.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAT4406F<br> | Drug: BAT4406F<br>* Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity（DLT） | Safety and tolerability endpoint | 4weeks | 
| Maximum tolerated dosed (MTD) | Safety and tolerability endpoint | up to 6 months | 
| Area under the curve (AUC) | Pharmacokinetic endpoint | up to 6 months | 
| Maximum serum drug concentration (Cmax) | Pharmacokinetic endpoint | up to 6 months | 
| Half-life period(t1/2) | Pharmacokinetic endpoint | up to 6 months | 
| Maximum serum drug time (Tmax) | Pharmacokinetic endpoint | up to 6 months | 
| CD19+ B lymphocyte ratio | Pharmacodynamics endpoint | up to 6 months |