A Phase Ib Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of B001 in Adults With Aquaporin-4 Antibody Positive Neuromyelitis Optic Spectrum Disorder

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of B001 injection in adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for aquaporin-4 antibodies. This early phase 1b study aims to understand how the drug behaves in the body, its immune response, and its preliminary effectiveness. The study focuses on participants who have experienced at least one NMOSD relapse within the past year and have a disability score ranging from 0 to 7.5. Participants are randomly assigned to receive either the B001 injection or a placebo. Each participant will receive two intravenous doses, one on day 1 and another on day 15, and will continue being monitored until the study ends. This double-blind design means neither the participants nor the researchers know who receives the active drug or placebo. The study includes a safety follow-up period extending up to one year and pharmacokinetic assessments continuing for up to two years. During the study, participants will undergo regular evaluations to monitor adverse effects, drug levels in the blood, immune response, and disability changes. Researchers will track treatment-emergent side effects, dose-limiting toxicities, and the timing and concentration of the drug in the bloodstream. They will also monitor relapse timing and progression of disability using standard scales over the course of the trial. Participants' health will be closely observed through laboratory tests and clinical assessments throughout the study duration.

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