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

NCT ID: NCT07245953

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-05
• Study Completion Date: 2027-05-31

Brief Summary

This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort A (HT-101 + HT-102)

Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Group Type: EXPERIMENTAL

HT-101

Intervention Type: DRUG

HT-101 given by subcutaneous injection

HT-102

Intervention Type: DRUG

HT-102 given by subcutaneous injection

Cohort B （placebo；HT-101+HT-102）

Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks

Group Type: EXPERIMENTAL

HT-101 placebo

Intervention Type: DRUG

HT-101 placebo given by subcutaneous injection

HT-102 placebo

Intervention Type: DRUG

HT-102 placebo given by subcutaneous injection

HT-101

Intervention Type: DRUG

HT-101 given by subcutaneous injection

HT-102

Intervention Type: DRUG

HT-102 given by subcutaneous injection

Interventions

HT-101 placebo

HT-101 placebo given by subcutaneous injection

Intervention Type: DRUG

HT-102 placebo

HT-102 placebo given by subcutaneous injection

Intervention Type: DRUG

HT-101

HT-101 given by subcutaneous injection

Intervention Type: DRUG

HT-102

HT-102 given by subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects were eligible for inclusion into the study if they met each of the following criteria:

Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m^2 (inclusive); Chronic HBV infection for >/= 6 months; The quantitation level of HBsAg was > 100 IU/mL and <3000 IU/mL; The quantitation level of HBV DNA <LLOQ;

· On Nas therapy for >/= 6 months at the time of screening Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;

Exclusion Criteria

• Subjects were excluded from the study if one or more of the following criteria were applicable Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou HepaThera Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinlin Hou

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, 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

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

Nanning, Guangxi, China

Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital)

Zhenjiang, Jiangsu, China

Nanchang Ninth Hospital

Nanchang, Jiangxi, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

HT-101&HT-102-201

Identifier Type: -

Identifier Source: org_study_id