Clinical trial
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT05332210
Sponsor:Harbour BioMed (Guangzhou) Co. Ltd.
Information provided by: Harbour BioMed (Guangzhou) Co. Ltd. (Responsible Party)
Last Update Posted: 2023-03-08
Brief 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.
OFFICIAL TITLE
A Long-term Open-label Extension Study to Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
INTERVENTION / TREATMENT
Drug: HBM9161 Injection (680mg)
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-06-30 |
| Primary Completion (Estimated) | 2023-09-30 |
| Study Completion (Estimated) | 2023-12-30 |
| Enrollment (Estimated) | 144 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | 9161.7 |