A Study of HBM9161 in NMOSD Patients

NMO Spectrum Disorder Clinical Trial

Official title: Safety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in China

Status Completed

Clinical Trial Summary

Primary Objectives:To investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China

Clinical Trial Description

This is an open-label, dose exploration study.The investigational drug is HBM9161 injection, and the indication is NMOSD. HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . By blocking the FcRn IgG-Fc binding site and accelerating the degradation of IgG, it can significantly reduce the total IgG level in blood (including pathological IgG).The serum aquaporin 4 antibody (AQP4-IgG) associated with NMOSD is a pathological IgG, so the combination of standard of care which is intravenous methylprednisolone (ivMP) with HBM9161 is expected to rapidly reduce AQP4-IgG levels. Two dose groups (340 mg and 680 mg) were planned, and each dose group plans to enroll approximately 6 subjects. All subjects are weekly administered the HBM9161 by subcutaneous injection for a period of 4 weeks, together with standard of care which is of intravenous methylprednisolone (ivMP) by subcutaneous for a period of 4 weeks. The study will investigate the safety, and tolerability, pharmacodynamics and efficacy of HBM 9161 in patients with attack of NMOSD in China. ;

Related Conditions & MeSH terms

• Neuromyelitis Optica
• NMO Spectrum Disorder

• NCT number: NCT04227470
• Study type: Interventional
• Source: Harbour BioMed (Guangzhou) Co. Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2020
• Completion date: December 24, 2021