Chronic Hepatitis BPhase 1NCT06744686
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients With Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity
A Phase 1 study testing HT-102 in people with Chronic Hepatitis B, run by Suzhou HepaThera Biotech Co., Ltd. at 7 sites in China.
Trial summary
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HT-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 7 sitesChina
- Study dates
- 12 Jun 2023to 18 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Participants SAD:
- Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
- Participants were healthy individuals;
- Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial;
- Participants with Chronic HBV infection, MAD:
- Chronic HBV infection, and HBeAg negative;
- Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;
Who cannot join
- Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
- Participants with major trauma or major surgery within 3 months before trial screening;
- Participants with a history of drug allergy;
- Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
- Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;
- Participants who cannot tolerate subcutaneous injection;
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- Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases;
- Participants with a clinically significant acute infection;
- Women who were pregnant or lactating or had a positive pregnancy test result;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 325035
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
Luoyang Central Hospital
Luoyang, Henan, 471000
People's Hospital of Qingyuan
Qingyuan, Guangdong, 511518
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, 450015
About this study
Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients With Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
- Conditions
- Chronic Hepatitis B
- Being tested
- 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-102Drug
50mg, 150mg, 300mg, 600mg
HT-102Drug
50mg, 150mg, 300mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A (Healthy participants administered with HT-102 or placebo) | Experimental | Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously Receives: Drug: HT-102; Drug: Placebo |
| Part B (Patients with CHB administered with HT-102 or placebo) | Experimental | Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week. Receives: Drug: HT-102; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From administration to the end of treatment at 8 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: From administration to the end of treatment at 8 weeks
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax)
Measured: From administration to the end of treatment o at 10 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: From administration to the end of treatment o at 10 weeks
Apparent Terminal Elimination Half-life (T1/2)
Measured: From administration to the end of treatment o at 10 weeks
Apparent Plasma Clearance (CL/F)
Measured: From administration to the end of treatment o at 10 weeks
Apparent volume of distribution（Vd/F）
Measured: From administration to the end of treatment o at 10 weeks
Change of Serum HBsAg From Baseline
Measured: From administration to the end of treatment o at 10 weeks
Change of Serum HBV DNA From Baseline
Measured: From administration to the end of treatment o at 10 weeks
Change of Serum HBV RNA From Baseline
Measured: From administration to the end of treatment o at 10 weeks
Change of Serum HBcrAg From Baseline
Measured: From administration to the end of treatment o at 10 weeks
Change of Serum HBcAb From Baseline
Measured: From administration to the end of treatment o at 10 weeks
Titers of Anti-drug Antibody (ADA) to HT-102
ADA analysis for predose and 8week (Part A) or 10weeks (Part B) postdose
Measured: From administration to the end of treatment o at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start12 Jun 2023
- Primary completion12 Mar 2024
- Study completion18 Jun 2024
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT06744686
- Sponsor's protocol ID
- HT-102-101
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients With Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
- ClinicalTrials.gov ID
- NCT06744686
- Acronym / sponsor ID
- HT-102-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 20 Dec 2024 (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.
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (Healthy participants administered with HT-102 or placebo) | Experimental | Drug: HT-102, Drug: PlaceboHealthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously |
| Part B (Patients with CHB administered with HT-102 or placebo) | Experimental | Drug: HT-102, Drug: PlaceboPatients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
- Participants were healthy individuals;
- Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial;
- Chronic HBV infection, and HBeAg negative;
- Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;
Key exclusion criteria (9 listed)
- Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
- Participants with major trauma or major surgery within 3 months before trial screening;
- Participants with a history of drug allergy;
- Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
- Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;
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-10250mg, 150mg, 300mg, 600mg | Drug | Part A (Healthy participants administered with HT-102 or placebo) |
| HT-10250mg, 150mg, 300mg | Drug | Part B (Patients with CHB administered with HT-102 or placebo) |
| PlaceboPlacebo | Drug | Part A (Healthy participants administered with HT-102 or placebo), Part B (Patients with CHB administered with HT-102 or placebo) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From administration to the end of treatment at 8 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: From administration to the end of treatment at 8 weeks
11 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: From administration to the end of treatment o at 10 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent Terminal Elimination Half-life (T1/2)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent Plasma Clearance (CL/F)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent volume of distribution（Vd/F）
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBsAg From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBV DNA From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBV RNA From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBcrAg From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBcAb From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Titers of Anti-drug Antibody (ADA) to HT-102
Time frame: From administration to the end of treatment o at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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 study testing 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 2 Nov 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From administration to the end of treatment at 8 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 2 Nov 2026.