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

NCT07059403 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CMG.2001.101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B Infection

Keywords

SN2001; Chronic hepatitis B infection (CHB); Hepatitis B infection (HBV); Healthy Adult Subjects

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  from the time of the first study injection through 48 Weeks after the final study injection

Secondary Outcomes (8)

• Serum SN2001 antibody titers.

  from before the first study injection through 24 Weeks after the final study injection

• Seroconversion (SN2001).

  from before the first study injection through 24 Weeks after the final study injection

• Serum HBV Core protein antibody titers.

  from before the first study injection through 24 Weeks after the final study injection

• Seroconversion (HBV Core protein).

  from before the first study injection through 24 Weeks after the final study injection

• Serum HBV PreS1/S2 protein antibody titers.

  from before the first study injection through 24 Weeks after the final study injection

Study Arms (3)

Cohort A

EXPERIMENTAL

Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.

Biological: SN2001

Cohort B

EXPERIMENTAL

Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.

Biological: SN2001

Cohort C

EXPERIMENTAL

Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.

Biological: SN2001

Interventions

SN2001 BIOLOGICAL

100 µg, for subcutaneous (SC) injection

Also known as: Placebo

Cohort A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Chimivac INC: lead

Study Sites (1)

Q-Pharm Pty Ltd.

Herston, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Development VP, PhD

CONTACT

+1-917-439-9820; contact@chimigen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 10, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)