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)

NCT06744686 ↗

Phase 1 Completed 56 enrolled Suzhou HepaThera Biotech Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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