drugset / Trial / NCT06744686
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
Timeline
- Start
- 2023-06-12
- Primary completion
- 2024-03-12
- Completion
- 2024-06-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HT-102 | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | HT-102 | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | HT-102 | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | HT-102 | Monoclonal antibody | 600 mg | Subcutaneous |