Hepatitis B
Conditions
Keywords
Hepatitis B, Hepatitis, Viral, Human, Virus Diseases, Bepirovirsen, GSK3228836, 219239, Liver Diseases
Brief summary
This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants. The aim of this study is to provide relative bioavailability data to support the transition from the vial presentation of bepirovirsen, to a ready-to-use liquid in a PFS SSD when both are given by a health care professional. The study will also assess self-administration using the PFS SDD, and the safety and tolerability of bepirovirsen.
Interventions
DRUGBepirovirsen
Bepirovirsen will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECGs) and vital signs. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol.
Exclusion criteria
* Past or current medical conditions which, in the judgement of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. * Abnormal blood pressure as determined by the investigator. * Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test results. * Participants with signs or symptoms suggestive of Coronavirus disease 2019 (COVID-19) within 14 days of inpatient admission, or with a positive test for active COVID-19 infection before study start. * Past, current or intended use of over the counter or prescription medication \[including herbal medications\] * Current or prior use of creatine-containing supplements and intended use up to 50 days post-dosing. Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing. * Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing. * Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5-half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before the first dosing day in the current study. * Current enrolment or past participation in this clinical study. * Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Regular alcohol consumption of alcohol within 6 months prior to the study. * Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC). * History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived. |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
| AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
| AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
Countries
United States
Participant flow
Pre-assignment details
A total of 160 participants were enrolled in the study which were randomized in 4 groups. (Enrolled Population: All participants who entered the study \[who were randomized or received study intervention or underwent a post-screening procedure\]).
Participants by arm
| Arm | Count |
|---|---|
| Bepirovirsen 300 mg Vial by HCP Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP). | 46 |
| Bepirovirsen 300 mg PFS SSD by HCP Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP. | 49 |
| Bepirovirsen 300 mg PFS SSD Self-administered Post-training Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. | 32 |
| Bepirovirsen 300 mg PFS SSD Self-administered Without Training Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. | 32 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 1 |
| Overall Study | Participants did not receive any study intervention | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Bepirovirsen 300 mg Vial by HCP | Bepirovirsen 300 mg PFS SSD by HCP | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.7 YEARS STANDARD_DEVIATION 9.09 | 36.5 YEARS STANDARD_DEVIATION 9.57 | 36.6 YEARS STANDARD_DEVIATION 9.35 | 37.5 YEARS STANDARD_DEVIATION 9.74 | 36.5 YEARS STANDARD_DEVIATION 9.35 |
| Race/Ethnicity, Customized All Other Races | 21 Participants | 29 Participants | 19 Participants | 14 Participants | 83 Participants |
| Race/Ethnicity, Customized WHITE | 25 Participants | 20 Participants | 13 Participants | 18 Participants | 76 Participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 15 Participants | 16 Participants | 82 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 17 Participants | 16 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 49 | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 45 / 46 | 43 / 49 | 32 / 32 | 30 / 32 |
| serious Total, serious adverse events | 0 / 46 | 0 / 49 | 0 / 32 | 0 / 32 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP | 112495.66 Hours*nanogram per milliliter (h*ng/mL) | Standard Error 0.039 |
| Bepirovirsen 300 mg PFS SSD by HCP | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP | 118622.59 Hours*nanogram per milliliter (h*ng/mL) | Standard Error 0.038 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.96, 1.15]
Primary
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP | 9954.89 Nanograms per milliliters (ng/mL) | Standard Error 0.049 |
| Bepirovirsen 300 mg PFS SSD by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP | 10163.74 Nanograms per milliliters (ng/mL) | Standard Error 0.048 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.91, 1.14]
Secondary
AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | 120034.02 Hours*nanograms per milliliters | Standard Error 0.038 |
| Bepirovirsen 300 mg PFS SSD by HCP | AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | 117805.29 Hours*nanograms per milliliters | Standard Error 0.05 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.88, 1.09]
Secondary
AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | 117938.68 Hours*nanograms per milliliters | Standard Error 0.037 |
| Bepirovirsen 300 mg PFS SSD by HCP | AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | 114492.19 Hours*nanograms per milliliters | Standard Error 0.049 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.87, 1.08]
Secondary
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | 10225.39 Nanograms per milliliters | Standard Error 0.05 |
| Bepirovirsen 300 mg PFS SSD by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | 10421.21 Nanograms per milliliters | Standard Error 0.067 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.88, 1.18]
Secondary
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Time frame: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bepirovirsen 300 mg Vial by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | 10007.69 Nanograms per milliliters | Standard Error 0.046 |
| Bepirovirsen 300 mg PFS SSD by HCP | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | 9896.63 Nanograms per milliliters | Standard Error 0.061 |
Comparison: Analysis was performed on the natural logarithms using a fixed-effects model.90% CI: [0.87, 1.13]