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

Phase 1

Recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorders
• Interventions: Drug: BAT4406F

• Registration Number: NCT04146285
• Lead Sponsor: Bio-Thera Solutions

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Study Start: 2020-09-01
• Primary Completion: 2023-03-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAT4406F	BAT4406F	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity（DLT）	4weeks	Safety and tolerability endpoint
Area under the curve (AUC)	up to 6 months	Pharmacokinetic endpoint
Maximum tolerated dosed (MTD)	up to 6 months	Safety and tolerability 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

Trial Locations

Locations (1)

Huashan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China