Clinical Trials Logo
  1. Home
  2. Myasthenia Gravis
  3. NCT04346888

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
See also
  Status Clinical Trial Phase
Completed NCT05039190 - Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients Phase 3
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT01727193 - The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy Phase 3
Completed NCT00285350 - Mycophenolate Mofetil in Myasthenia Gravis Phase 3
Recruiting NCT05890833 - The Risk of Falls Index for Patients With Neuromuscular Disorders
Completed NCT05694234 - Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Not yet recruiting NCT05095103 - Immune Profiles in Myasthenia Gravis
Not yet recruiting NCT04965987 - Oxaloacetate in Myasthenia Gravis Phase 1
Completed NCT02774239 - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) Phase 3
Completed NCT02066519 - Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis N/A
Terminated NCT02102594 - Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) Phase 2
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Terminated NCT01828294 - Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis Phase 1
Terminated NCT00727194 - Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT04590716 - Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Recruiting NCT04837625 - Study of Myasthenic Crisis in China
Not yet recruiting NCT01469858 - Perception and Multisensory Integration in Neurological Patients Using fMRI N/A
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Completed NCT03205306 - Myasthenia Gravis and Psyche