drugset / Trial / NCT04568265
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy of APG-1387 in combination with entecavir, and to determine the optimal dose of APG-1387 in combination with entecavir.
Timeline
- Start
- 2020-06-03
- Primary completion
- 2022-10-31
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-1387 | Small molecule | 12 mg | Intravenous |
| Subject | APG-1387 | Small molecule | 20 mg | Intravenous |
| Subject | APG-1387 | Small molecule | 30 mg | Intravenous |
| Subject | Entecavir | Small molecule | 0.5 mg | Oral |