drugset / Trial / NCT05332210
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
NaSingle-groupOpen-labelTreatment
Summary
The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.
Timeline
- Start
- 2022-06-30
- Primary completion
- 2024-04-26
- Completion
- 2024-04-26
Outcome
Met primary endpoint
release “Data received from the phase III trial met primary endpoint as well as key secondary endpoints.” harbourbiomed.com ↗
release “Data from the trial met the primary endpoint as well as key secondary endpoints.” hanall.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batoclimab | Monoclonal antibody | 680 mg | Subcutaneous |