Clinical trial NCT04146285: A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
Official title: A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Dose-limiting toxicity（DLT）
timeFrame: 4weeks
measure: Maximum tolerated dosed (MTD)
timeFrame: up to 6 months
measure: Area under the curve (AUC)
timeFrame: up to 6 months
measure: Maximum serum drug concentration (Cmax)
timeFrame: up to 6 months
measure: Half-life period(t1/2)
timeFrame: up to 6 months
measure: Maximum serum drug time (Tmax)
timeFrame: up to 6 months
measure: CD19+ B lymphocyte ratio
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xiangjun Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References: