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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions

Criteria

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.