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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
Sponsor: Suzhou HepaThera Biotech Co., Ltd.
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2023-06-12
Completion Date
2024-06-18
Last Updated
2026-11-02
Healthy Volunteers
Yes
Conditions
Interventions
HT-102
50mg, 150mg, 300mg, 600mg
HT-102
50mg, 150mg, 300mg
Placebo
Placebo
Locations (7)
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
People's Hospital of Qingyuan
Qingyuan, Guangdong, China
Luoyang Central Hospital
Luoyang, Henan, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China