Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults

A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of SN2001 in Healthy Adult Subjects

A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults (NCT07059403) is a Phase 1 interventional studying Chronic Hepatitis B Infection, sponsored by Chimivac INC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Chronic Hepatitis B Infection, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 to 55 years, inclusive. 2. Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2. 3. 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. 4. 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. 5. 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 - 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. 6. 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. 7. Willing to comply with the study requirements and to provide written willing to sign a consent form. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age 18 to 55 years, inclusive. 2. Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2. 3. 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. 4. 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. 5. 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 * 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. 6. 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. 7. Willing to comply with the study requirements and to provide written informed consent. Exclusion Criteria: 1. History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens. 2. 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. 3. Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks. 4. 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 * 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. 5. 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. 6. 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. 7. 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. 8. History of Cancer within 3 years, excluding basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia, which is cured is allowed. 9. Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus. 10. History of any severe trauma or major surgical condition within 3 months or planned to undergo surgery during the study period. 11. 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. 12. Used prescription drugs or vaccines within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. 13. 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. 14. 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. 15. 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). 16. 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. 17. 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. 18. History of significant local or systemic reactogenicity (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration). 19. Donated more than 400 mL of blood within 30 days before the first dose of study drug. 20. 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.

Treatments Being Tested

BIOLOGICAL

SN2001

100 µg, for subcutaneous (SC) injection

BIOLOGICAL

SN2001

200 µg, for subcutaneous (SC) injection

BIOLOGICAL

SN2001

300 µg, for subcutaneous (SC) injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Q-Pharm Pty Ltd.
Herston, Queensland, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07059403), the sponsor (Chimivac INC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07059403 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07059403?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07059403?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07059403. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07059403. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.