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ACTIVE NOT RECRUITING
NCT07183306
PHASE1/PHASE2

A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection

Sponsor: Suzhou HepaThera Biotech Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HT-101

HT-101 given by subcutaneous injection.

DRUG

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