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

Bio-Thera Solutions

Status and phase

Enrolling

Phase 1

Conditions

Neuromyelitis Optica Spectrum Disorders

Treatments

Drug: BAT4406F

Study type

Interventional

Funder types

Industry

Identifiers

NCT04146285

BAT-4406F-001-CR

Details and patient eligibility

About

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

Full description

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.