Trials / Recruiting
RecruitingNCT05145361
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
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)
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | B001 injection | B001 injection 50mg/5mL Intravenous solution |
| BIOLOGICAL | Placebo | Placebo 5mL Intravenous solution |
Timeline
- Start date
- 2022-04-07
- Primary completion
- 2025-12-15
- Completion
- 2025-12-15
- First posted
- 2021-12-06
- Last updated
- 2025-08-17
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05145361. Inclusion in this directory is not an endorsement.