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

NCT07245953 | Active Not Recruiting Phase 2

• 1 other identifier: HT-101&HT-102-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60

  From enrollment to the end of treatment at up to 60 weeks

Secondary Outcomes (10)

• Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment

  From enrollment to the end of treatment at up to 60 weeks

• HBsAg loss rate at W24, W36, W60

  From enrollment to the end of treatment at up to 60 weeks

• Maximum Change of Serum HBsAg From Baseline Description

  Up to 36 weeks

• Maximum Change of Serum HBV DNA From Baseline Description

  Up to 36 weeks.

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  From enrollment to the end of treatment at up to 60 weeks

Study Arms (2)

Cohort A (HT-101 + HT-102)

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102

Cohort B （placebo；HT-101+HT-102）

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102; Drug: HT-101 placebo; Drug: HT-102 placebo

Interventions

HT-101 DRUG

HT-101 given by subcutaneous injection

Cohort A (HT-101 + HT-102); Cohort B （placebo；HT-101+HT-102）

HT-102 DRUG

HT-102 given by subcutaneous injection

Cohort A (HT-101 + HT-102); Cohort B （placebo；HT-101+HT-102）

HT-101 placebo DRUG

HT-101 placebo given by subcutaneous injection

Cohort B （placebo；HT-101+HT-102）

HT-102 placebo DRUG

HT-102 placebo given by subcutaneous injection

Cohort B （placebo；HT-101+HT-102）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou HepaThera Biotech Co., Ltd.: lead

Study Sites (12)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350028, China

Location

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510440, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

Location

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

Nanning, Guangxi, 530011, China

Location

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

Zhengzhou, Henan, 450000, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, 210003, China

Location

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

Zhenjiang, Jiangsu, 212021, China

Location

Nanchang Ninth Hospital

Nanchang, Jiangxi, 330022, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinlin Hou

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (12)