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Chronic Hepatitis BPhase 2NCT07245953

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

A Phase 2 study testing HT-101 and HT-102 in people with Chronic Hepatitis B, run by Suzhou HepaThera Biotech Co., Ltd. at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
HT-101 and HT-102
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
12 sitesChina
Study dates
5 Nov 2025to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

  • Guangzhou Eighth People's Hospital, Guangzhou Medical University

    Guangzhou, Guangdong, 510440

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Nanchang Ninth Hospital

    Nanchang, Jiangxi, 330022

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

  • Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

    Nanning, Guangxi, 530011

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 200083

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

    Zhengzhou, Henan, 450000

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

    Zhenjiang, Jiangsu, 212021

Other trials in China

About this study

Official title: 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.

Being tested
HT-101, HT-102, HT-101 placebo, HT-102 placebo
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HT-101Drug

    HT-101 given by subcutaneous injection

  • HT-102Drug

    HT-102 given by subcutaneous injection

  • HT-101 placeboDrug

    HT-101 placebo given by subcutaneous injection

  • HT-102 placeboDrug

    HT-102 placebo given by subcutaneous injection

Study groups in NCT07245953
Study groupRoleWhat they receive
Cohort A (HT-101 + HT-102)ExperimentalParticipants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Receives: Drug: HT-101; Drug: HT-102
Cohort B （placebo；HT-101+HT-102）ExperimentalParticipants 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
Receives: Drug: HT-101; Drug: HT-102; Drug: HT-101 placebo; Drug: HT-102 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (10)

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

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

  2. HBsAg loss rate at W24, W36, W60

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

  3. 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)

    Measured: Up to 36 weeks

  4. 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)

    Measured: Up to 36 weeks.

  5. 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

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

  6. Clinically significant abnormalities

    Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0

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

  7. 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.

    Measured: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

  8. 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.

    Measured: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

  9. 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.

    Measured: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

  10. Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101

    ADA analysis for predose 36weeks

    Measured: UP to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start5 Nov 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245953
Sponsor's protocol ID
HT-101&HT-102-201
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HT-101 and HT-102 in people with Chronic Hepatitis B, run by Suzhou HepaThera Biotech Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From enrollment to the end of treatment at up to 60 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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