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

NCT05145361 | Recruiting Early Phase 1

• 1 other identifier: B001-103
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

NMO Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Measurement of DLT in all subjects.

  Up to 18 days.

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

  Up to 1 year

Secondary Outcomes (16)

• Maximum serum concentration (Cmax) of B001.

  Through study completion, up to 2 years

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

  Through study completion, up to 2 years

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

  Through study completion, up to 2 years

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

  Through study completion, up to 2 years

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

  Through study completion, up to 2 years

Study Arms (2)

B001 injection

EXPERIMENTAL

Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.

Drug: B001 injection

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.

Biological: Placebo

Interventions

B001 injection DRUG

B001 injection 50mg/5mL Intravenous solution

B001 injection

Placebo BIOLOGICAL

Placebo 5mL Intravenous solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (4)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

Tangdu hospital,fourth military medical university

Xi’an, Shanxi, 710038, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 42079612 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fu-Dong Shi, MD,PhD

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu-Dong Shi, MD,PhD

CONTACT

022-60814587; Shifudong219@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 6, 2021
• Study Start: April 7, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-08

Locations

CN (4)