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

Sponsor
Bio-Thera Solutions (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04146285
Collaborator
(none)
48
Enrollment
1
Location
1
Arm
24.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
Anticipated Study Start Date :
Nov 5, 2019
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BAT4406F

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

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity（DLT） [4weeks]

    Safety and tolerability endpoint

  2. Maximum tolerated dosed (MTD) [up to 6 months]

    Safety and tolerability endpoint

  3. Area under the curve (AUC) [up to 6 months]

    Pharmacokinetic endpoint

  4. Maximum serum drug concentration (Cmax) [up to 6 months]

    Pharmacokinetic endpoint

  5. Half-life period(t1/2) [up to 6 months]

    Pharmacokinetic endpoint

  6. Maximum serum drug time (Tmax) [up to 6 months]

    Pharmacokinetic endpoint

  7. CD19+ B lymphocyte ratio [up to 6 months]

    Pharmacodynamics endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital affiliated to Fudan University Shanghai Shanghai China

Sponsors and Collaborators

  • Bio-Thera Solutions

Investigators

  • Principal Investigator: Xiangjun Chen, Huashan Hospital
  • Principal Investigator: Jing Zhang, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bio-Thera Solutions
ClinicalTrials.gov Identifier:
NCT04146285
Other Study ID Numbers:
  • BAT-4406F-001-CR
First Posted:
Oct 31, 2019
Last Update Posted:
Oct 31, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuromyelitis Optica

Study Results

No Results Posted as of Oct 31, 2019