Chronic Hepatitis BPhase 1/2NCT07183306
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
A Phase 1/2 study testing HT-101 and HT-102 in people with Chronic Hepatitis B, run by Suzhou HepaThera Biotech Co., Ltd. at 7 sites in China.
Trial summary
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesChina
- Study dates
- 30 Dec 2024to 3 May 2028
- Phase
- Phase 1/2
- 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 65 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 ≥ 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;
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
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510440
Nanfang Hospital
Guangzhou, Guangdong, 510515
Qingyuan People's Hospital
Qingyuan, Guangdong, 511518
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200083
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, 361001
About this study
Official title: A 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
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.
- Conditions
- Chronic Hepatitis B
- Being tested
- HT-101, HT-102
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort A (HT-101) | Experimental | Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks Receives: Drug: HT-101 |
| Experimental: Cohort AA (HT-101) | Experimental | Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks Receives: Drug: HT-101 |
| Experimental: Cohort B （HT-102；HT-101） | Experimental | Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks Receives: Drug: HT-101; Drug: HT-102 |
| Experimental: Cohort C (HT-101 + HT-102) | Experimental | Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks Receives: Drug: HT-101; Drug: HT-102 |
| Experimental: Cohort D (HT-101 + HT-102) | Experimental | Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks Receives: Drug: HT-101; Drug: HT-102 |
| Experimental: Cohort E (HT-101 + HT-102) | Experimental | Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks Receives: Drug: HT-101; Drug: HT-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Secondary outcomes (9)
Maximum Plasma Concentration (Cmax)
Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101: From predose 1 hour to postdose 24 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 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101：From predose 1 hour to postdose 24 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 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent Plasma Clearance (CL/F)
CL/F of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent volume of distribution（Vd/F）
Vd/F of HT-101. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.
Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Measured: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Maximum Change of Serum HBsAg From Baseline
Maximum change of serum HBsAg from Day 1 until 48 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)
Measured: Up to 48 weeks
Maximum Change of Serum HBV DNA From Baseline
Maximum change of serum HBV DNA from Day 1 until 48 weeks (negative values mean reductions from baseline, positive values mean increased from baseline).
Measured: Up to 48 weeks
Titers of Anti-drug Antibody (ADA) to HT-102
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.
- First posted19 Sep 2025
- Study start30 Dec 2024
- Primary completion24 Aug 2027 (estimated)
- Study completion3 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183306
- Sponsor's protocol ID
- HT-101&HT-102-101
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT07183306
- Acronym / sponsor ID
- HT-101&HT-102-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 3 May 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort A (HT-101) | Experimental | Drug: HT-101Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks |
| Experimental: Cohort AA (HT-101) | Experimental | Drug: HT-101Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks |
| Experimental: Cohort B （HT-102；HT-101） | Experimental | Drug: HT-101, Drug: HT-102Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks |
| Experimental: Cohort C (HT-101 + HT-102) | Experimental | Drug: HT-101, Drug: HT-102Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks |
| Experimental: Cohort D (HT-101 + HT-102) | Experimental | Drug: HT-101, Drug: HT-102Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks |
| Experimental: Cohort E (HT-101 + HT-102) | Experimental | Drug: HT-101, Drug: HT-102Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT-101HT-101 given by subcutaneous injection. | Drug | Experimental: Cohort A (HT-101), Experimental: Cohort AA (HT-101), Experimental: Cohort B （HT-102；HT-101）, Experimental: Cohort C (HT-101 + HT-102), Experimental: Cohort D (HT-101 + HT-102), Experimental: Cohort E (HT-101 + HT-102) |
| HT-102HT-102 given by subcutaneous injection. | Drug | Experimental: Cohort B （HT-102；HT-101）, Experimental: Cohort C (HT-101 + HT-102), Experimental: Cohort D (HT-101 + HT-102), Experimental: Cohort E (HT-101 + HT-102) |
Primary outcome
Clinically significant abnormalities
Time frame: From enrollment to the end of treatment at up to 60 weeks
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From enrollment to the end of treatment at up to 60 weeks
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
9 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: HT-101: From predose 1 hour to postdose 24 hours HT-102：UP to 36 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent Terminal Elimination Half-life (T1/2)
Time frame: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent Plasma Clearance (CL/F)
Time frame: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Apparent volume of distribution（Vd/F）
Time frame: HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks
Maximum Change of Serum HBsAg From Baseline
Time frame: Up to 48 weeks
Maximum Change of Serum HBV DNA From Baseline
Time frame: Up to 48 weeks
Titers of Anti-drug Antibody (ADA) to HT-102
Time frame: UP to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HT-101 and HT-102 in people with Chronic Hepatitis B, run by Suzhou HepaThera Biotech Co., Ltd. at 7 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 5 inclusion and 2 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 7 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinically significant abnormalities (time frame: From enrollment to the end of treatment at up to 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.