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

A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: HT-101; Drug: HT-102; Drug: HT-101 placebo; Drug: HT-102 placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100015
      • Beijing Ditan Hospital Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350028
      • Mengchao Hepatobiliary Hospital OF Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital
    • Guangzhou, Guangdong, China, 510440
      • Guangzhou Eighth People's Hospital, Guangzhou Medical University
    • Qingyuan, Guangdong, China, 511518
      • Qingyuan People's Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530011
      • Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • The Second Hospital of Nanjing
    • Zhenjiang, Jiangsu, China, 212021
      • Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital)
  • Jiangxi
    • Nanchang, Jiangxi, China, 330022
      • Nanchang Ninth Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200083
      • Shanghai Public Health Clinical Center
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A (HT-101 + HT-102); Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks	Drug: HT-101; HT-101 given by subcutaneous injection; Drug: HT-102; HT-102 given by subcutaneous injection
Experimental: 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	Drug: HT-101; HT-101 given by subcutaneous injection; Drug: HT-102; HT-102 given by subcutaneous injection; Drug: HT-101 placebo; HT-101 placebo given by subcutaneous injection; Drug: HT-102 placebo; HT-102 placebo given by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Maximum change of serum HBsAg from Day 1 until 36 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)	Up to 36 weeks
Maximum Change of Serum HBV DNA From Baseline Description	Maximum change of serum HBV DNA from Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline)	Up to 36 weeks.
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From enrollment to the end of treatment at up to 60 weeks
Clinically significant abnormalities	Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0	From enrollment to the end of treatment at up to 60 weeks
Maximum Plasma Concentration (Cmax)	Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.	HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Time to Reach Maximum Plasma Concentration (Tmax)	Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.	HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Area Under the Plasma Concentration Versus Time Curve (AUC)	AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.	HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101	ADA analysis for predose 36weeks	UP to 36 weeks

Collaborators and Investigators

• Sponsor: Suzhou HepaThera Biotech Co., Ltd.
• Investigators: Study Chair: Jinlin Hou, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: HT-101&HT-102-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No