drugset / Trial / NCT02569372
A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in Chronic Hepatitis B Patients.
Timeline
- Start
- 2015-11-09
- Primary completion
- 2017-10-12
- Completion
- 2017-10-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LENVERVIMAB | Monoclonal antibody | 80000 iu | Intravenous |
| Subject | LENVERVIMAB | Monoclonal antibody | 120000 iu | Intravenous |
| Subject | LENVERVIMAB | Monoclonal antibody | 180000 iu | Intravenous |
| Subject | LENVERVIMAB | Monoclonal antibody | 240000 iu | Intravenous |