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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT04146285
• Date of registration: 26/09/2019
• Prospective Registration: Yes
• Primary sponsor: Bio-Thera Solutions
• Public title: A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
• Scientific title: A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
• Date of first enrolment: September 1, 2020
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04146285
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Qiang Wei

• Name: Xiangjun Chen

• Name: Xiangjun Chen
• Affiliation: Huashan Hospital

• Name: Jing Zhang
• Affiliation: Huashan Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica Spectrum Disorders

Intervention(s)

Drug: BAT4406F

Primary Outcome(s)

Dose-limiting toxicity(DLT) [Time Frame: 4weeks]

Maximum tolerated dosed (MTD) [Time Frame: up to 6 months]

Half-life period(t1/2) [Time Frame: up to 6 months]

Area under the curve (AUC) [Time Frame: up to 6 months]

CD19+ B lymphocyte ratio [Time Frame: up to 6 months]

Maximum serum drug concentration (Cmax) [Time Frame: up to 6 months]

Maximum serum drug time (Tmax) [Time Frame: up to 6 months]

Secondary ID(s)

BAT-4406F-001-CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors