Neuromyelitis Optica Spectrum Disorders
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGBAT4406F
Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.
Sponsors
Bio-Thera Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity（DLT） | 4weeks | Safety and tolerability endpoint |
| Maximum tolerated dosed (MTD) | up to 6 months | Safety and tolerability endpoint |
| Area under the curve (AUC) | up to 6 months | Pharmacokinetic endpoint |
| Maximum serum drug concentration (Cmax) | up to 6 months | Pharmacokinetic endpoint |
| Half-life period(t1/2) | up to 6 months | Pharmacokinetic endpoint |
| Maximum serum drug time (Tmax) | up to 6 months | Pharmacokinetic endpoint |
| CD19+ B lymphocyte ratio | up to 6 months | Pharmacodynamics endpoint |
Countries
China
Outcome results
None listed