A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)

November 4, 2026 updated by: Suzhou HepaThera Biotech Co., Ltd.

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of HT-101 Injection in Combination With HT-102 Injection in Participants With Chronic Hepatitis B (CHB) Virus Infection

Phase II trial of HT-101 + HT-102 in CHB: (1) functional cure in treatment-naïve patients (vs placebo); (2) efficacy of sequential interferon in previously treated patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II clinical trial to evaluate the efficacy and safety of HT-101 Injection in combination with HT-102 Injection in participants with chronic hepatitis B virus infection. The primary objective is（1） to assess the efficacy of HT-101 Injection plus HT-102 Injection compared with placebo in achieving functional cure in treatment-naïve participants with chronic hepatitis B virus infection

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Having a full understanding of the nature, significance, possible benefits, and risks of this study, demonstrating good compliance, and voluntarily signing the Informed Consent Form (ICF)；
  2. Treatment-naïve participants clinically diagnosed with chronic Hepatitis B virus (HBV) infection;
  3. Male or female participants of childbearing potential (WOCBP) must commit to having no plans for procreation, sperm or ovum donation during the study and for 6 months after the last dose, and must voluntarily use a highly effective contraceptive method.

Exclusion Criteria:

  1. Previous history of cirrhosis, or evidence suggesting significant hepatic fibrosis or cirrhosis;
  2. History of hepatocellular carcinoma (HCC) or suspected HCC;
  3. Individuals who have experienced major trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo major surgery during the study period;
  4. Previous history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT);
  5. Pregnant or lactating women, or those with a positive pregnancy test;
  6. Known allergy to any component of the investigational product and/or other products of the same class, or history of severe food or drug allergy, or allergic constitution;
  7. Participants deemed by the investigator, for any other reason, to be unsuitable to participate in this study;

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HT-101 + HT-102
Drug: HT-101 + HT-102

HT-101 given by subcutaneous injection.HT-102 given by subcutaneous injection.
Experimental: HT-101 placebo + HT-102 placebo
Drug: HT-101 placebo + HT-102 placebo

HT-101 placebo + HT-102 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving functional cure at Week 24 of follow-up after discontinuation of all anti-hepatitis B medications.
Time Frame: Up to Week 72
Up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou HepaThera Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

September 17, 2029

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-101&HT-102-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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