Neuromyelitis Optica Spectrum Disorders
Conditions
Interventions
50mg:BAT4406F, 50mg, Intravenous infusion
100mg:BAT4406F, 100mg, Intravenous infusion
Other dosing group:BAT4406F, other doses are to be administered depending on the circumstances, Intravenous infusion
20mg:BAT4406F, 20mg, Intravenous infusion
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All of the following criteria are eligible for inclusion: 1) Compliance with the NMOSD diagnostic criteria developed by the 2015 International NMO Diagnostic Team (IPND); 2) Aged 18-65 years old, male or female; 3) At least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening; 4) Discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline; 5) EDSS score <= 6; 6) Men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion; 7) Agree to participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1)Any monoclonal antibody treatment was used within 6 months prior to dosing; 2)Having been treated with anti-CD20 monoclonal antibody; 3)Live vaccine received within 4 weeks before screening; 4)Having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer); 5)A history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs; 6)Abnormal liver function, kidney function and bone marrow reserve; 7)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; 8)History of infections that investigators have identified as unsuitable for testing; 9)Patients with a clear history of heart disease; 10)Have a history of mental disorders; 11)Pregnant or lactating women, and female subjects who have a positive pregnancy test at screening; 12) None of the investigators or their relatives participating in the study could be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;DLT;PK;pharmacodynamics; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADA;preliminary effectiveness; | — |
Countries
China
Contacts
Public ContactXiangjun Chen
Huashan Hospital affiliated to Fudan University
Outcome results
None listed