Suspended

HT-101 and HT-102 Injections for Chronic Hepatitis B

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

HT-101

+ HT-102

Drug
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorSuzhou HepaThera Biotech Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 30, 2024

Actual date on which the first participant was enrolled.

This clinical study aims to explore the safety and effects of two new injections, HT-101 and HT-102, in patients who have chronic hepatitis B virus infection. Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus, and it can lead to serious liver problems. The study seeks to understand how the body handles these new medications and how they affect the virus. By researching these injections, there is hope to find more effective treatments for managing chronic hepatitis B, improving the quality of life for those affected. Participants in the study will receive injections of HT-101 and/or HT-102 every four weeks, over a period of at least 24 weeks. Some groups will receive just HT-101, others just HT-102, and some will receive a combination of both. Throughout the study, all participants will also continue their existing treatment with nucleoside analogues, a common therapy for hepatitis B. The study will closely monitor the participants to evaluate the safety and side effects of the injections, as well as how well the medications work in managing the infection.

Official TitleA 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
NCT07183306
Principal SponsorSuzhou HepaThera Biotech Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsHepatitis B, ChronicDisease Attributes

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 ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks

Group II

Experimental
Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks

Group III

Experimental
Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks

Group IV

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

Group 5

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

Group 6

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Beijing Ditan Hospital Capital Medical University

Beijing, ChinaOpen Beijing Ditan Hospital Capital Medical University in Google Maps
Suspended

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, China
Suspended

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, China
Suspended

Nanfang Hospital

Guangzhou, China
Suspended7 Study Centers