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)

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Suzhou HepaThera Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HT-102	50mg, 150mg, 300mg, 600mg
DRUG	HT-102	50mg, 150mg, 300mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-06-12
• Primary completion: 2024-03-12
• Completion: 2024-06-18
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

7 sites across 1 country: China