Neuromyelitis Optica Spectrum DisordersPhase 1NCT04146285
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
A Phase 1 study testing BAT4406F in people with Neuromyelitis Optica Spectrum Disorders, run by Bio-Thera Solutions at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- BAT4406F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 25 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.
Read the 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.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Being tested
- BAT4406F
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT4406FDrug
Open-label dose escalation starting from 20mg.
Route of administration: intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| BAT4406F | Experimental | Not described Receives: Drug: BAT4406F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Safety and tolerability endpoint
Measured: 4weeks
Maximum tolerated dosed (MTD)
Safety and tolerability endpoint
Measured: up to 6 months
Area under the curve (AUC)
Pharmacokinetic endpoint
Measured: up to 6 months
Maximum serum drug concentration (Cmax)
Pharmacokinetic endpoint
Measured: up to 6 months
Half-life period(t1/2)
Pharmacokinetic endpoint
Measured: up to 6 months
Maximum serum drug time (Tmax)
Pharmacokinetic endpoint
Measured: up to 6 months
CD19+ B lymphocyte ratio
Pharmacodynamics endpoint
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Sep 2020
- Primary completion13 Mar 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangjun Chen, Principal investigator, Huashan HospitalJing Zhang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146285
- Sponsor's protocol ID
- BAT-4406F-001-CR
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2019
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu H, Chen Y, Qi Y, Yang H, Cao G, Yang W, Li S, Yang X, Wang H, Zhang J, Chen X. First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients With Neuromyelitis Optica Spectrum Disorders. CNS Neurosci Ther. 2024 Nov;30(11):e70126. doi: 10.1111/cns.70126.
PubMed 39592888
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04146285
- Acronym / sponsor ID
- BAT-4406F-001-CR
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT4406F | Experimental | Drug: BAT4406F |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT4406FOpen-label dose escalation starting from 20mg. Route of administration: intravenous infusion. | Drug | BAT4406F |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: 4weeks
Safety and tolerability endpoint
Maximum tolerated dosed (MTD)
Time frame: up to 6 months
Safety and tolerability endpoint
Area under the curve (AUC)
Time frame: up to 6 months
Pharmacokinetic endpoint
Maximum serum drug concentration (Cmax)
Time frame: up to 6 months
Pharmacokinetic endpoint
Half-life period(t1/2)
Time frame: up to 6 months
Pharmacokinetic endpoint
Maximum serum drug time (Tmax)
Time frame: up to 6 months
Pharmacokinetic endpoint
CD19+ B lymphocyte ratio
Time frame: up to 6 months
Pharmacodynamics endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 39592888Yu H, Chen Y, Qi Y, Yang H, Cao G, Yang W, Li S, Yang X, Wang H, Zhang J, Chen X. First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients With Neuromyelitis Optica Spectrum Disorders. CNS Neurosci Ther. 2024 Nov;30(11):e70126. doi: 10.1111/cns.70126.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangjun Chen principal investigator
Huashan Hospital
Jing Zhang principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAT4406F in people with Neuromyelitis Optica Spectrum Disorders, run by Bio-Thera Solutions at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: 4weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.