Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients

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Trial Identification

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

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

Study ID: NCT04346888

Conditions

Myasthenia Gravis

Interventions

HBM9161 Injection (680mg and 340 mg)

Placebos

HBM9161 Injection (340 mg)

Study Description

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

Detailed 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.