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NCT Number: NCT04146285

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

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

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAT4406F

Drug

Open-label dose escalation starting from 20mg.

Route of administration: intravenous infusion.

Primary outcomes

  1. Dose-limiting toxicity（DLT）

    Time frame: 4weeks

    Safety and tolerability endpoint

  2. Maximum tolerated dosed (MTD)

    Time frame: up to 6 months

    Safety and tolerability endpoint

  3. Area under the curve (AUC)

    Time frame: up to 6 months

    Pharmacokinetic endpoint

  4. Maximum serum drug concentration (Cmax)

    Time frame: up to 6 months

    Pharmacokinetic endpoint

  5. Half-life period(t1/2)

    Time frame: up to 6 months

    Pharmacokinetic endpoint

  6. Maximum serum drug time (Tmax)

    Time frame: up to 6 months

    Pharmacokinetic endpoint

  7. CD19+ B lymphocyte ratio

    Time frame: up to 6 months

    Pharmacodynamics endpoint

Sponsors and collaborators

Lead sponsor

Bio-Thera Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2019
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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