Trials / Completed
CompletedNCT04346888
A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-07-23
- Primary completion
- 2021-08-24
- Completion
- 2021-08-24
- First posted
- 2020-04-15
- Last updated
- 2023-03-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04346888. Inclusion in this directory is not an endorsement.