drugset / Trial / NCT05332210

Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

NCT05332210 ↗

Phase 3 Completed 111 enrolled Harbour BioMed (Guangzhou) Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Batoclimab Monoclonal antibody 680 mg Subcutaneous

Indications