Chronic Hepatitis B InfectionPhase 1NCT07059403
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
A Phase 1 study testing SN2001 in people with Chronic Hepatitis B Infection, run by Chimivac INC at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B Infection
- What is being tested?
- SN2001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Aug 2025to Apr 2027
- Phase
- Phase 1
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2.
- Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. A postmenopausal state should be confirmed by at least 12 months since last menstrual period and FSH > 40 IU.
- Women of childbearing potential (WOCBP) may be enrolled in the study if the participant:
- has practiced highly-effective contraception for 28 days prior to first injection, and
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- has a negative pregnancy test at Screening, and
- agrees to refrain from ova donation from Screening until 48 weeks after completion of the final injection, and
- practices abstinence as part of her usual and preferred lifestyle, and
- has agreed to continue highly-effective contraception from Screening until 48 weeks after completion of the final injection.
- Male participants:
- with documented bilateral orchiectomy, or
- agrees to practice abstinence from penile-vaginal intercourse or use condoms from Screening until 48 weeks after completion of the final subcutaneous injection, and
- agrees to refrain from sperm donation from Screening until 48 weeks after completion of the final injection, and
- the highly effective contraceptive methods listed above should also apply to WOCBP partners of male participants for the specified duration, in addition to male condom use, from Screening until 48 weeks after completion of the final injection.
- Willing to comply with the study requirements and to provide written informed consent.
Who cannot join
- History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens.
- Clinical laboratory evidence of active infection with human immunodeficiency virus (HIV) infection, or hepatitis C virus (HCV) infection, or hepatitis A virus (HAV), or hepatitis D virus (HDV), or syphilis and/or any other chronic viral infection.
- Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.
- History of HBV vaccination:
- Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or
- Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) and a seroprotective Hepatitis B surface antibody (HBsAb) titre <10 milli-international units per milliliter (mIU/mL) at screening, or
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- Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) within 6 months prior to the screening visit, or
- Have HBV vaccination scheduled plan within 48 weeks after the final study drug dosing.
- Receipt of any investigational drug or vaccine or medical device clinical trial within 3 months or 5 half-lives (whichever is greater) prior to screening.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin greater than or equal to 1.5×ULN, or any other laboratory values considered clinically significant abnormalities and unacceptable by the Investigator at screening.
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or renal disease (such as chronic liver disease), gastrointestinal tract disease, respiratory disease, metabolism, skeletal system diseases or other conditions known to put the subject at significant risk.
- History of Cancer within 3 years, excluding basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia, which is cured is allowed.
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.
- History of any severe trauma or major surgical condition within 3 months or planned to undergo surgery during the study period.
- Presently receiving (or history of receiving), during the preceding 3 months or 5 half-lives (whichever is greater), any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids, intranasal corticosteroids (e.g. Nasonex for allergic rhinitis) are allowed.
- Used prescription drugs or vaccines within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Used over-the-counter (OTC) medication or herbal supplements, excluding routine vitamins, within 7 days before the first dose of study drug, unless determined by the Investigator and the Sponsor to be not clinically relevant and unlikely to impact on study outcomes. Paracetamol or ibuprofen can be considered an exception for the treatment of headaches or any other pain for eligibility purposes.
- Participants smoke ≥ 10 cigarettes a day within 3 months before screening, or those who cannot stop using any tobacco products from screening until 24 weeks after the final injection.
- History or clinical evidence of alcohol abuse, within the 3 months before screening, and unwillingness to abstain from alcohol within 3 weeks after the final study drug dosing. Alcohol abuse is defined as regular weekly intake of more than 14 units for male and 10 units for female (unit: 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer).
- History or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or were stopping or a reduction in dose will lead to withdrawal symptoms.
- Confirmed positive results from drug of abuse (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, cotinine, tricyclic anti-depressants) or from the alcohol breath test at screening.
- History of significant local or systemic reactogenicity (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration).
- Donated more than 400 mL of blood within 30 days before the first dose of study drug.
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of SN2001 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.
- Conditions
- Chronic Hepatitis B Infection
- Being tested
- SN2001
- Keywords
- SN2001, Chronic hepatitis B infection (CHB), Hepatitis B infection (HBV), Healthy Adult Subjects
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN2001Biological
Also called Placebo
100 µg, for subcutaneous (SC) injection
SN2001Biological
Also called Placebo
200 µg, for subcutaneous (SC) injection
SN2001Biological
Also called Placebo
300 µg, for subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo. Receives: Biological: SN2001 |
| Cohort B | Experimental | Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo. Receives: Biological: SN2001 |
| Cohort C | Experimental | Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo. Receives: Biological: SN2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Number of subjects with AEs assessed by the 2007 FDA Guidance to Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Solicited local injection site reactions and solicited systemic symptoms on the day of each study injection and for 7 days.
Non-serious unsolicited AEs will be collected until 21 days after 1st, 2nd, and 3rd study injection, and until 28 days after last study injection.
All serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) must be collected from the time of the first study injection through 48 weeks after the final study injection.
Measured: from the time of the first study injection through 48 Weeks after the final study injection
Number of subjects with clinically significant abnormalities in vital signs graded by 2007 FDA Guidance.
Vital sign measurements include blood pressure, pulse rate, respiratory rate and temperature.
The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Measured: from the time of the first study injection through 48 Weeks after the final study injection
Number of subjects with clinically significant abnormalities in physical examination graded by 2007 FDA Guidance.
A full physical examination will include general appearance, head, neck, chest/respiratory, heart/cardiovascular, gastrointestinal/liver, extremities, skin, and neurological assessments.
The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Measured: from the time of the first study injection through 48 Weeks after the final study injection
Number of subjects with clinically significant abnormalities in 12-lead electrocardiogram (ECG) graded by 2007 FDA Guidance.
12-lead ECGs will include heart rate, PR intervals, QRS intervals, QT intervals, and QTcF intervals.
The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Measured: from the time of the first study injection through 48 Weeks after the final study injection
Number of subjects with clinically significant abnormalities in laboratory parameters graded by 2007 FDA Guidance.
Laboratory parameters will include hematology, chemistry, coagulation parameters, urinalysis, etc.
The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized in all parameters.
Mean change and shift from baseline to each scheduled post-baseline visit will be summarized in all quantitative parameters.
Measured: from the time of the first study injection through 48 Weeks after the final study injection
Secondary outcomes (8)
Serum SN2001 antibody titers.
Serum SN2001 antibody titers will be measured by enzyme linked immunosorbent assay (ELISA).
Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.
Measured: from before the first study injection through 24 Weeks after the final study injection
Seroconversion (SN2001).
Serum SN2001 antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies [i.e., concentrations/titer greater than or equal to the lower limit of quantification (LLOQ)] in the serum of subjects seronegative before investigational product administration.
Measured: from before the first study injection through 24 Weeks after the final study injection
Serum HBV Core protein antibody titers.
Serum HBV Core protein antibody titers will be measured by ELISA. Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.
Measured: from before the first study injection through 24 Weeks after the final study injection
Seroconversion (HBV Core protein).
Serum HBV Core protein antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies (i.e., concentrations/titer greater than or equal to the LLOQ) in the serum of subjects seronegative before investigational product administration.
Measured: from before the first study injection through 24 Weeks after the final study injection
Serum HBV PreS1/S2 protein antibody titers.
Serum HBV PreS1/S2 protein antibody titers will be measured by ELISA. Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.
Measured: from before the first study injection through 24 Weeks after the final study injection
Seroconversion (HBV PreS1/S2 protein).
Serum HBV PreS1/S2 protein antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies (i.e., concentrations/titer greater than or equal to the LLOQ) in the serum of subjects seronegative before investigational product administration.
Measured: from before the first study injection through 24 Weeks after the final study injection
Frequency of HBV core-specific IFN-γ-secreting peripheral blood mononuclear cells (PBMCs).
HBV core-specific IFN-γ-secreting PBMCs is measured by immunosorbent spot (ELISpot) assay. Frequency of HBV core-specific IFN-γ-secreting PBMCs is expressed as HBV core-specific T-cells per million peripheral blood mononuclear cells (HBV core-specific IFN-γ-secreting PBMCs /million PBMCs).
Measured: from before the first study injection through 24 Weeks after the final study injection
Frequency of HBV core-specific IL-4-secreting peripheral blood mononuclear cells (PBMCs).
HBV core-specific IL-4-secreting PBMCs is measured by immunosorbent spot (ELISpot) assay. Frequency of HBV core-specific IL-4-secreting PBMCs is expressed as HBV core-specific T-cells per million peripheral blood mononuclear cells (HBV core-specific IL-4-secreting PBMCs /million PBMCs).
Measured: from before the first study injection through 24 Weeks after the final study injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start19 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimivac INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059403
- Sponsor's protocol ID
- CMG.2001.101
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No