A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
NCT04346888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-03-08
Summary
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
Conditions
Interventions
- DRUG
-
HBM9161 Injection (680mg and 340 mg)
HBM9161 Injection (680mg and 340mg)
- DRUG
-
Placebos
Placebo, HBM9161 Injection (340mg)
- DRUG
-
HBM9161 Injection (340 mg)
HBM9161 Injection (340 mg)
Sponsors & Collaborators
-
Harbour BioMed (Guangzhou) Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Chongbo Zhao · Huashan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-23
- Primary Completion
- 2021-08-24
- Completion
- 2021-08-24
Countries
- China
Study Locations
More Related Trials
-
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
NCT04818671 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
NCT07246564 ·Status: RECRUITING ·Phase: PHASE4
-
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
NCT00727194 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
NCT03863080 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
NCT04735432 ·Status: COMPLETED ·Phase: PHASE3
-
Myasthenia Gravis Inebilizumab Trial
NCT04524273 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
NCT07250750 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Clinical Prognosis and Progression of Myasthenia Gravis Patients
NCT04101578 ·Status: UNKNOWN
-
A Study in Patients With Myasthenia Gravis in China
NCT06700616 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of HBM9161 in NMOSD Patients
NCT04227470 ·Status: COMPLETED ·Phase: PHASE1
-
A Prospective Cohort Study of Myasthenia Gravis in China
NCT06006832 ·Status: RECRUITING
-
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
NCT07039916 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
NCT05728684 ·Status: UNKNOWN ·Phase: NA
-
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
NCT05403541 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects
NCT07054034 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Telitacicept in Generalized Myasthenia Gravis
NCT05737160 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
NCT02473952 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis
NCT00004682 ·Status: TERMINATED ·Phase: NA
-
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03772587 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
NCT04951622 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
NCT03052751 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT06414954 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
NCT03920293 ·Status: COMPLETED ·Phase: PHASE3
-
An Exploratory Clinical Study of GC012F Injection for Refractory gMG
NCT06419166 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
NCT04535843 ·Status: RECRUITING