Recruiting
Early Phase 1
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
Condition(s) studied
NMO Spectrum Disorder
Investigational drug(s) / intervention(s)
B001 injection: B001 injection 50mg/5mL Intravenous solution
Placebo: Placebo 5mL Intravenous solution
Study 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.
Eligibility
Inclusion Criteria:
1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
4. Age 18 to 70 years, inclusive at the time of informed consent
Exclusion Criteria:
1. 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.
2. 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.
3. 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.
4. Known active infection within 3 months prior to baseline
5. Pregnancy or lactation.
6. History of severe allergic reaction to a biologic agent
7. Evidence of chronic active hepatitis B or C
8. Evidence of active tuberculosis
9. Following laboratory abnormalities at screening\*:
1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL)
2. Absolute neutrophil count (ANC)
3. Absolute lymphocyte count \<0.5 x10\^3/μL
4. Platelet count \<80 x 10\^9/ L
5. Aspartate aminotransferase (AST) or alanine aminotransferase
10. History of drug or alcohol abuse within 6 months prior to baseline
11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
12. 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.
Primary outcome measure(s)
- Dose-limiting toxicity (DLT) — Up to 18 days.
Measurement of DLT in all subjects.
- Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability]. — Up to 1 year
Trial sites (4)
| Facility | City | Region | Status |
| Beijing Tiantan Hospital Capital Medical University |
Beijing |
Beijing Municipality |
Recruiting |
| First Hospital of Shanxi Medical University |
Taiyuan |
Shanxi |
Recruiting |
| Tangdu hospital,fourth military medical university |
Xi’an |
Shanxi |
Recruiting |
| Tianjin Medical University General Hospital |
Tianjin |
Tianjin Municipality |
Recruiting |
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