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A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients

Myasthenia Gravis Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

Clinical Trial Summary

Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China

Clinical Trial Description

This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG. The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04346888
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact
Status Completed
Phase Phase 2
Start date July 23, 2020
Completion date August 24, 2021
View Details
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