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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07059403




Registration number
NCT07059403
Ethics application status
Date submitted
20/06/2025
Date registered
10/07/2025
Date last updated
10/07/2025

Titles & IDs
Public title
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
CMG.2001.101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SN2001
Treatment: Other - SN2001
Treatment: Other - SN2001

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

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

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


Treatment: Other: SN2001
100 µg, for subcutaneous (SC) injection

Treatment: Other: SN2001
200 µg, for subcutaneous (SC) injection

Treatment: Other: SN2001
300 µg, for subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
from the time of the first study injection through 48 Weeks after the final study injection
Primary outcome [2] 0 0
Number of subjects with clinically significant abnormalities in vital signs graded by 2007 FDA Guidance.
Timepoint [2] 0 0
from the time of the first study injection through 48 Weeks after the final study injection
Primary outcome [3] 0 0
Number of subjects with clinically significant abnormalities in physical examination graded by 2007 FDA Guidance.
Timepoint [3] 0 0
from the time of the first study injection through 48 Weeks after the final study injection
Primary outcome [4] 0 0
Number of subjects with clinically significant abnormalities in 12-lead electrocardiogram (ECG) graded by 2007 FDA Guidance.
Timepoint [4] 0 0
from the time of the first study injection through 48 Weeks after the final study injection
Primary outcome [5] 0 0
Number of subjects with clinically significant abnormalities in laboratory parameters graded by 2007 FDA Guidance.
Timepoint [5] 0 0
from the time of the first study injection through 48 Weeks after the final study injection
Secondary outcome [1] 0 0
Serum SN2001 antibody titers.
Timepoint [1] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [2] 0 0
Seroconversion (SN2001).
Timepoint [2] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [3] 0 0
Serum HBV Core protein antibody titers.
Timepoint [3] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [4] 0 0
Seroconversion (HBV Core protein).
Timepoint [4] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [5] 0 0
Serum HBV PreS1/S2 protein antibody titers.
Timepoint [5] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [6] 0 0
Seroconversion (HBV PreS1/S2 protein).
Timepoint [6] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [7] 0 0
Frequency of HBV core-specific IFN-?-secreting peripheral blood mononuclear cells (PBMCs).
Timepoint [7] 0 0
from before the first study injection through 24 Weeks after the final study injection
Secondary outcome [8] 0 0
Frequency of HBV core-specific IL-4-secreting peripheral blood mononuclear cells (PBMCs).
Timepoint [8] 0 0
from before the first study injection through 24 Weeks after the final study injection

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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. Receipt of any HBV vaccination within 12 months prior to the screening visit and Hepatitis B surface antibody (HBsAb) concentrations = 200 milli-international units per milliliter (mIU/mL) at screening, or planning HBV vaccination scheduled 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chimivac INC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Development VP, PhD
Address 0 0
Country 0 0
Phone 0 0
+1-917-439-9820
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07059403