Back to resultsA Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
Primary Purpose
Neuromyelitis Optica Spectrum Disorders
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BAT4406F
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorders
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.
Sites / Locations
- Huashan Hospital affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BAT4406F
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting toxicity（DLT）
Safety and tolerability endpoint
Maximum tolerated dosed (MTD)
Safety and tolerability endpoint
Area under the curve (AUC)
Pharmacokinetic endpoint
Maximum serum drug concentration (Cmax)
Pharmacokinetic endpoint
Half-life period(t1/2)
Pharmacokinetic endpoint
Maximum serum drug time (Tmax)
Pharmacokinetic endpoint
CD19+ B lymphocyte ratio
Pharmacodynamics endpoint
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04146285
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-Thera Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BAT4406F
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAT4406F
Intervention Description
Open-label dose escalation starting from 20mg.
Route of administration: intravenous infusion.
Primary Outcome Measure Information:
Title
Dose-limiting toxicity（DLT）
Description
Safety and tolerability endpoint
Time Frame
4weeks
Title
Maximum tolerated dosed (MTD)
Description
Safety and tolerability endpoint
Time Frame
up to 6 months
Title
Area under the curve (AUC)
Description
Pharmacokinetic endpoint
Time Frame
up to 6 months
Title
Maximum serum drug concentration (Cmax)
Description
Pharmacokinetic endpoint
Time Frame
up to 6 months
Title
Half-life period(t1/2)
Description
Pharmacokinetic endpoint
Time Frame
up to 6 months
Title
Maximum serum drug time (Tmax)
Description
Pharmacokinetic endpoint
Time Frame
up to 6 months
Title
CD19+ B lymphocyte ratio
Description
Pharmacodynamics endpoint
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Wei
Phone
17768126490
Email
qwei@bio-thera.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangjun Chen
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangjun Chen
Phone
18221382327
Email
xiangjchen@fudan.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
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