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

Neuromyelitis Optica Spectrum Disorders Clinical Trial

Official title:

A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146285
• Other study ID #: BAT-4406F-001-CR
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2023
• Source: Bio-Thera Solutions
• Contact: Qiang Wei
• Phone: 17768126490
• Email: qwei[@]bio-thera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders

Intervention

Drug:
• BAT4406F
Open-label dose escalation starting from 20mg. Route of administration: intravenous infusion.

Locations

Country	Name	City	State
China	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity(DLT)	Safety and tolerability endpoint	4weeks
Primary	Maximum tolerated dosed (MTD)	Safety and tolerability endpoint	up to 6 months
Primary	Area under the curve (AUC)	Pharmacokinetic endpoint	up to 6 months
Primary	Maximum serum drug concentration (Cmax)	Pharmacokinetic endpoint	up to 6 months
Primary	Half-life period(t1/2)	Pharmacokinetic endpoint	up to 6 months
Primary	Maximum serum drug time (Tmax)	Pharmacokinetic endpoint	up to 6 months
Primary	CD19+ B lymphocyte ratio	Pharmacodynamics endpoint	up to 6 months