Chronic Hepatitis B Virus InfectionPhase 1NCT07515209
A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients
A Phase 1 study testing HH-006 and 0.9% normal saline in people with Chronic Hepatitis B Virus Infection, run by Huahui Health at 3 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending doses (120 mg, 240 mg, 480 mg SC, QW×5) of HH-006 in untreated chronic HBV patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B Virus Infection
- What is being tested?
- HH-006 and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- 20 Dec 2024to 15 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 18 to 60 years (inclusive);
- Male weight ≥ 45 kg, female weight ≥ 40 kg, and body mass index (BMI, BMI = weight/height²): 18 kg/m² ≤ BMI ≤ 32 kg/m²;
- HBsAg positive for more than 6 months (including 6 months), and with 100 IU/mL < HBsAg < 5000 IU/mL prior to randomization;
- HBV DNA ≥ 100 IU/mL prior to randomization;
- ALT ≤ 5 × ULN prior to randomization;
- No prior interferon antiviral therapy within 1 year before the screening period, and no prior treatment with nucleos(t)ide analogues within 6 months before the screening period;
- Males not having undergone sterilization surgery and females not postmenopausal for less than two years must agree to use adequate and effective contraceptive measures from screening until the last follow-up visit of the study (including hormonal contraceptives, intrauterine devices, cervical caps, or condoms);
- Subjects must understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.
Who cannot join
- Females who are pregnant, breastfeeding, or have a positive pregnancy test at baseline with childbearing potential.
- Co-infection with hepatitis C, syphilis, or HIV.
- History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease, or other clinically significant chronic liver diseases not caused by HBV.
- History of or concurrent progressive liver fibrosis or cirrhosis;
- History of or concurrent hepatocellular carcinoma, or at screening: blood alpha-fetoprotein (AFP) ≥ 50 ng/mL; or imaging examinations such as liver ultrasound, CT, or MRI suggest possible hepatocellular carcinoma.
- Clinically significant ECG abnormalities;
Show all 19Show fewer
- Concurrent severe diseases of other systems or clinical conditions that, in the investigator's judgment, make the subject unsuitable for participation in this study:
- Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.
- Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease (COPD), etc.
- Primary or secondary renal diseases: e.g., chronic renal decompensation and renal diseases secondary to diabetes, hypertension, vascular diseases, etc.
- Endocrine system diseases: e.g., poorly controlled diabetes or thyroid disease, etc.
- Autoimmune diseases: e.g., systemic lupus erythematosus, primary thrombocytopenic purpura, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.
- Neuropsychiatric diseases: e.g., epilepsy, schizophrenia, etc. Malignancies.
- At screening: total bilirubin > 1.1 × ULN or direct bilirubin > 1.1 × ULN; hemoglobin < 120 g/L (male) or < 110 g/L (female); platelets < 100,000/mm³ (100 × 109/L); absolute neutrophil count < 1,500/mm³ (1.5 × 109/L); serum albumin < 35 g/L; prothrombin time international normalized ratio (INR) > 1.3; estimated glomerular filtration rate (eGFR, MDRD formula) < 60 mL/min/1.73 m².
- History of sustained alcohol consumption (average daily alcohol intake > 40 g for males, > 20 g for females) or illicit drug abuse within 6 months prior to screening (including the screening period).
- Participation in any clinical trial of a drug (except for those who did not receive the investigational drug) or medical device (except for non-invasive medical devices) within 3 months prior to screening, or being within 5 half-lives of a prior drug at the time of screening.
- Significant trauma or major surgery within 3 months prior to screening.
- Known allergy to antibody-based drugs or to any component of the investigational drug.
- Individuals judged by the investigator to be unsuitable for participation in this study, or those with a close relationship to the study center: e.g., relatives of the investigator, affiliated personnel (e.g., staff or students of the study center).
Trial locations and contacts
3 sites in 1 country.
China3 sites
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The Eighth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Antiviral Activity of Multiple Doses of HH-006 Injection in Untreated Chronic Hepatitis B Virus Infected Individuals
This is a randomized, double-blind, placebo-controlled Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending doses (120 mg, 240 mg, 480 mg SC, QW×5) of HH-006 in untreated chronic HBV patients. Each cohort includes 12 participants (9 active, 3 placebo), with dose progression approved by a Safety Review Committee. Participants are monitored through 24 weeks post-dose. The study design allows for adjustments based on emerging data.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multiple-dose escalation Phase I clinical study. The study aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antiviral activity of multiple doses (120 mg QW, 240 mg QW, 480 mg QW, administered subcutaneously (S.C.) once weekly (QW) for 5 doses) in chronic hepatitis B virus (HBV) infected participants who are not receiving anti-HBV treatment, are HBeAg-negative or positive, have HBV DNA ≥ 100 IU/mL, 100 IU/mL < HBsAg < 5000 IU/mL, and ALT ≤ 5 × ULN.
Each dose cohort plans to enroll 12 participants, enrolled in batches according to the dose escalation principle. Participants will be randomized to receive either HH-006 (N=9) or placebo (N=3) for a repeated-dose (5 doses) tolerability and pharmacokinetic study.
Dosing for the next cohort will commence only after all 12 participants in the current dose cohort have completed the safety assessment up to 14 days post-last dose (Week 7, Day 43) and after review and approval by the Safety Review Committee. The currently planned maximum dose for escalation is 480 mg QW.
Each participant is planned to be followed up for 24 weeks after the last dose to assess the safety, tolerability, PK, immunogenicity, and preliminary antiviral activity of HH-006 in participants with chronic HBV infection. During the study, adjustments to the maximum dose, dosing regimen, blood sampling time points, and follow-up duration may be made based on the accumulating data obtained during the study.
Throughout the study, participants' safety indicators and virologic parameters will be closely monitored to evaluate the safety and antiviral activity of HH-006.
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- HH-006, 0.9% normal saline
- Keywords
- chronic hepatitis B virus infection, safety, pharmacokinetics, antiviral activity
- 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.
HH-006Biological
120 mg, 240 mg, 480 mg subcutaneous QW, 5 doses
0.9% normal salineDrug
1 mL, 2 mL, 4 mL subcutaneous QW, 5 doses
| Study group | Role | What they receive |
|---|---|---|
| HH-006 | Experimental | Not described Receives: Biological: HH-006 |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: up to 24 weeks follow-up
Clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Measured: up to 24 weeks follow-up
Secondary outcomes (7)
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-006 in plasma
Measured: up to 24 weeks follow-up
Maximum Plasma Concentration (Cmax)
Cmax of HH-006 in plasma
Measured: up to 24 weeks follow-up
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-006 in plasma
Measured: up to 24 weeks follow-up
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-006 in plasma
Measured: up to 24 weeks follow-up
Apparent Plasma Clearance (CL/F)
CL/F of HH-006 in plasma
Measured: up to 24 weeks follow-up
Immunogenicity: ADA
Measured: up to 24 weeks follow-up
Antiviral Activity: Change in HBV DNA levels from baseline (at each study time point); Change in HBsAg levels from baseline (at each study time point)
Measured: up to 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start20 Dec 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515209
- Sponsor's protocol ID
- HH006-102
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Antiviral Activity of Multiple Doses of HH-006 Injection in Untreated Chronic Hepatitis B Virus Infected Individuals
- ClinicalTrials.gov ID
- NCT07515209
- Acronym / sponsor ID
- HH006-102
- Conditions
- Chronic Hepatitis B Virus Infection
- Keywords
- chronic hepatitis B virus infection, safety, pharmacokinetics, antiviral activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 7 Apr 2026 (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 is a randomized, double-blind, placebo-controlled Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending doses (120 mg, 240 mg, 480 mg SC, QW×5) of HH-006 in untreated chronic HBV patients. Each cohort includes 12 participants (9 active, 3 placebo), with dose progression approved by a Safety Review Committee. Participants are monitored through 24 weeks post-dose. The study design allows for adjustments based on emerging data.
Detailed description
This is a randomized, double-blind, placebo-controlled, multiple-dose escalation Phase I clinical study. The study aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antiviral activity of multiple doses (120 mg QW, 240 mg QW, 480 mg QW, administered subcutaneously (S.C.) once weekly (QW) for 5 doses) in chronic hepatitis B virus (HBV) infected participants who are not receiving anti-HBV treatment, are HBeAg-negative or positive, have HBV DNA ≥ 100 IU/mL, 100 IU/mL < HBsAg < 5000 IU/mL, and ALT ≤ 5 × ULN.
Each dose cohort plans to enroll 12 participants, enrolled in batches according to the dose escalation principle. Participants will be randomized to receive either HH-006 (N=9) or placebo (N=3) for a repeated-dose (5 doses) tolerability and pharmacokinetic study.
Dosing for the next cohort will commence only after all 12 participants in the current dose cohort have completed the safety assessment up to 14 days post-last dose (Week 7, Day 43) and after review and approval by the Safety Review Committee. The currently planned maximum dose for escalation is 480 mg QW.
Each participant is planned to be followed up for 24 weeks after the last dose to assess the safety, tolerability, PK, immunogenicity, and preliminary antiviral activity of HH-006 in participants with chronic HBV infection. During the study, adjustments to the maximum dose, dosing regimen, blood sampling time points, and follow-up duration may be made based on the accumulating data obtained during the study.
Throughout the study, participants' safety indicators and virologic parameters will be closely monitored to evaluate the safety and antiviral activity of HH-006.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-006 | Experimental | Biological: HH-006 |
| Placebo | Placebo comparator | Drug: 0.9% normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female aged 18 to 60 years (inclusive);
- Male weight ≥ 45 kg, female weight ≥ 40 kg, and body mass index (BMI, BMI = weight/height²): 18 kg/m² ≤ BMI ≤ 32 kg/m²;
- HBsAg positive for more than 6 months (including 6 months), and with 100 IU/mL < HBsAg < 5000 IU/mL prior to randomization;
- HBV DNA ≥ 100 IU/mL prior to randomization;
- ALT ≤ 5 × ULN prior to randomization;
Key exclusion criteria (19 listed)
- Females who are pregnant, breastfeeding, or have a positive pregnancy test at baseline with childbearing potential.
- Co-infection with hepatitis C, syphilis, or HIV.
- History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease, or other clinically significant chronic liver diseases not caused by HBV.
- History of or concurrent progressive liver fibrosis or cirrhosis;
- History of or concurrent hepatocellular carcinoma, or at screening: blood alpha-fetoprotein (AFP) ≥ 50 ng/mL; or imaging examinations such as liver ultrasound, CT, or MRI suggest possible hepatocellular carcinoma.
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 |
|---|---|---|
| HH-006120 mg, 240 mg, 480 mg subcutaneous QW, 5 doses | Biological | HH-006 |
| 0.9% normal saline1 mL, 2 mL, 4 mL subcutaneous QW, 5 doses | Drug | Placebo |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to 24 weeks follow-up
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Clinically significant abnormalities
Time frame: up to 24 weeks follow-up
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
7 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: up to 24 weeks follow-up
Maximum Plasma Concentration (Cmax)
Time frame: up to 24 weeks follow-up
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: up to 24 weeks follow-up
Apparent Terminal Elimination Half-life (T1/2)
Time frame: up to 24 weeks follow-up
Apparent Plasma Clearance (CL/F)
Time frame: up to 24 weeks follow-up
Immunogenicity: ADA
Time frame: up to 24 weeks follow-up
Antiviral Activity: Change in HBV DNA levels from baseline (at each study time point); Change in HBsAg levels from baseline (at each study time point)
Time frame: up to 24 weeks follow-up
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 7 Apr 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.
3 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 HH-006 and 0.9% normal saline in people with Chronic Hepatitis B Virus Infection, run by Huahui Health at 3 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 8 inclusion and 19 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: up to 24 weeks follow-up). 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 7 Apr 2026.