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NMO Spectrum DisorderEarly Phase 1NCT05145361

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

A Early Phase 1 study testing B001 injection in people with NMO Spectrum Disorder, run by Shanghai Pharmaceuticals Holding Co., Ltd at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NMO Spectrum Disorder
What is being tested?
B001 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
4 sitesChina
Study dates
7 Apr 2022to 15 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
  • Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
  • Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
  • Age 18 to 70 years, inclusive at the time of informed consent

Who cannot join

  • Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
  • Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
  • Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
  • Known active infection within 3 months prior to baseline
  • Pregnancy or lactation.
  • History of severe allergic reaction to a biologic agent
Show all 17Show fewer
  • Evidence of chronic active hepatitis B or C
  • Evidence of active tuberculosis
  • Following laboratory abnormalities at screening*:
  • White blood cells (WBC) <4.0 x10^3/microliter (μL)
  • Absolute neutrophil count (ANC)
  • Absolute lymphocyte count <0.5 x10^3/μL
  • Platelet count <80 x 10^9/ L
  • Aspartate aminotransferase (AST) or alanine aminotransferase
  • History of drug or alcohol abuse within 6 months prior to baseline
  • Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
  • Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fu-Dong Shi, MD,PhD contact

022-60814587

Shifudong219@163.com

China4 sites, 4 recruiting

  • Beijing Tiantan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100050

    Yunxing Song, +86 17813230827, songyx@sphchina.com

    Xinghu Zhang

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Yunxing Song, +86 17813230827, songyx@sphchina.com

    Meini Zhang

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Chao Zhang, MD, 022-60814587, chaozhang@tmu.edu.can

    Fu-Dong Shi, MD,PhD

    Recruiting

  • Tangdu hospital,fourth military medical university

    Xi’an, Shanxi, 710038

    Shicao Li, 0086-029-84717761, tangduec@126.com

    Jun Guo

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.

Being tested
B001 injection, Placebo
Medical subject headings
Neuromyelitis Optica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B001 injectionDrug

    B001 injection 50mg/5mL Intravenous solution

  • PlaceboBiological

    Placebo 5mL Intravenous solution

Study groups in NCT05145361
Study groupRoleWhat they receive
B001 injectionExperimentalSubjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.
Receives: Drug: B001 injection
PlaceboPlacebo comparatorSubjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Measurement of DLT in all subjects.

    Measured: Up to 18 days.

  2. Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].

    Measured: Up to 1 year

Secondary outcomes (16)

  1. Maximum serum concentration (Cmax) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  2. Time of maximum serum concentration (Tmax) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  3. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  4. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  5. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  6. Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  7. Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  8. Terminal rate constant(λz) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  9. Half-life (t1/2) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  10. Total clearance(CL) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  11. Volume of distribution(Vz) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  12. Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.

    To characterize the PK (Pharmacokinetics) of B001.

    Measured: Through study completion, up to 2 years

  13. Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)

    Measured: Through study completion, up to 2 years

  14. Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period

    Measured: Through study completion, up to 2 years

  15. Change in Expanded Disability Status Scale (EDSS) Score

    The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score.

    Measured: Through study completion, up to 2 years

  16. Time to EDSS Worsening

    Measured: Through study completion, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start7 Apr 2022
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145361
Sponsor's protocol ID
B001-103
Status last verified
Aug 2025
First submitted
21 Nov 2021
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jia D, Wang H, Jiang W, Shen Y, Guo J, Zhao D, Zhang M, Meng H, Xue H, Song Y, Yao Q, Xie N, Zhang C. A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial. Front Immunol. 2026 Apr 16;17:1676908. doi: 10.3389/fimmu.2026.1676908. eCollection 2026.

    PubMed 42079612

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing B001 injection in people with NMO Spectrum Disorder, run by Shanghai Pharmaceuticals Holding Co., Ltd at 4 sites 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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fu-Dong Shi, MD,PhD (022-60814587, Shifudong219@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Up to 18 days.). The study lists 2 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 NCT05145361, 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 5 May 2026.

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