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A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Sponsor: Suzhou HepaThera Biotech Co., Ltd.
Summary
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.
Official title: A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-101 Injection and/or HT-102 Injection in Patients With Chronic Hepatitis B Virus Infection
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2024-12-30
Completion Date
2027-05-03
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
HT-101
HT-101 given by subcutaneous injection.
HT-102
HT-102 given by subcutaneous injection.
Locations (7)
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China