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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Q-Pharm Pty Ltd.
Herston, Queensland, Australia
RECRUITINGIncidence 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: from the time of the first study injection through 48 Weeks after the final study injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: from before the first study injection through 24 Weeks after the final study injection