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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
Not provided
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This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepirovirsen: Four-Dose SC Injection | Active Comparator | Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. |
|
| Placebo: Four SC Injections | Placebo Comparator | Participants received four matching placebo SC injections on Day 1. |
|
| Bepirovirsen: Three-Dose SC Injection | Active Comparator | Participant received three SC injections of Bepirovirsen dose level 1 on Day 1. |
|
| Placebo: Three SC Injections | Placebo Comparator | Participants received three matching placebo SC injections on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepirovirsen | Drug | Bepirovirsen was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose | Continuous 12-lead electrocardiogram (ECG) was captured by Holter monitor. QTcF was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline (CFB) was calculated by subtracting post-dose visit value from Baseline value. Geometric mean and 90 percent (%) Confidence Interval (CI) of predicted CFB QTcF adjusted for placebo at Cmax following supratherapeutic single doses of Bepirovirsen was presented using concentration QTc (C-QTc) analysis using exposure-response modelling. This approach utilized pre-specified linear mixed effects model where CFB QTcF was dependent variable. Fixed-effect parameters included intercept, slope, influence of Baseline on intercept, treatment and nominal time from first dose. Participant was included as additive random effect on both intercept and slope terms. | Baseline (Pre-dose on Day 1) and Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in RR Interval in ECG at Indicated Timepoints | Twelve-lead ECGs were extracted from continuous Holter monitor tracings and RR interval was measured. RR interval is the time duration between the peak of one R wave and the peak of the very next R wave on the ECG. RR interval represents the time between two consecutive heartbeats. ECGs were extracted after a 10 minute supine rest period. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
Inclusion Criteria:
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs.
Body weight greater than equal to (>=) 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m^2) (inclusive).
Study will enroll both male and female participants.
o Female participants are eligible to participate if they are not pregnant or breastfeeding and are either not of childbearing potential or agree to using a highly effective method of contraception.
Capable of giving signed informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 -1645 | United States |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bepirovirsen: Four-Dose SC Injection | Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. |
| FG001 | Placebo: Four SC Injections | Participants received four matching placebo SC injections on Day 1. |
| FG002 | Bepirovirsen: Three-Dose SC Injection | Participant received three SC injections of Bepirovirsen dose level 1 on Day 1. |
| FG003 | Placebo: Three SC Injections | Participants received three matching placebo SC injections on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bepirovirsen: Four-Dose SC Injection | Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. |
| BG001 | Placebo: Four SC Injections | Participants received four matching placebo SC injections on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose | Continuous 12-lead electrocardiogram (ECG) was captured by Holter monitor. QTcF was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline (CFB) was calculated by subtracting post-dose visit value from Baseline value. Geometric mean and 90 percent (%) Confidence Interval (CI) of predicted CFB QTcF adjusted for placebo at Cmax following supratherapeutic single doses of Bepirovirsen was presented using concentration QTc (C-QTc) analysis using exposure-response modelling. This approach utilized pre-specified linear mixed effects model where CFB QTcF was dependent variable. Fixed-effect parameters included intercept, slope, influence of Baseline on intercept, treatment and nominal time from first dose. Participant was included as additive random effect on both intercept and slope terms. | Analysis was performed on pharmacokinetic (PK)/QTcF set that included all participants who were in both the QT/QTcF and PK populations with at least 1 pair of post dose PK and CFB QTcF data from the same time point as well as participants in the QT/QTcF population who received placebo. This outcome measure intended to provide Placebo-corrected data. | Posted | Geometric Mean | 90% Confidence Interval | Milliseconds | Baseline (Pre-dose on Day 1) and Day 4 |
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Day 50
Safety set included participants who received study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bepirovirsen: Four-Dose SC Injection | Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2024 | Apr 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2025 | Apr 27, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a double-blind study.
| Placebo | Drug | Placebo was administered. |
|
| Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints | Continuous 12-lead ECG was captured by Holter monitor. QTcF, PR interval and QRS duration were measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| Number of Participants With Outlier Results for Heart Rate (HR) | Continuous 12-lead ECG was captured by Holter monitor. HR was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Participants with HR less than (<) 50 beats per minute (bpm) with a decrease of HR greater than (>) 25% and HR >100 bpm with an increase of HR >25% were considered as outlier. | Up to Day 4 |
| Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration | Twelve-lead ECG were obtained to measure QTcF interval, PR interval and QRS duration. 12-lead ECG were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Participants with outlier results were determined if the following criteria (which were assessed separately) were met: Participant who had treatment-emergent (TE) value of QTcF>450 and <=480 milliseconds (ms) when not present at Baseline (new onset); TE value of QTcF>480 and <=500 ms when not present at Baseline (new onset); TE value of QTcF>500 ms when not present at Baseline (new onset); increase of QTcF from Baseline of >30 and <=60 ms; increase of QTcF from baseline >60 ms; Increase in PR interval from Baseline >25% resulting in PR >200 ms; increase in QRS duration from Baseline >25% resulting in QRS >120 ms. | Up to Day 4 |
| Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence | Twelve-lead ECG were obtained using an ECG machine. T-wave morphology was categorized as follows: Flat T wave: T amplitude <1 millimeter (mm) (either positive or negative) including flat isoelectric line. Notched T wave(+): Presence of notch(es) of at least 0.05 millivolt(mV) amplitude on ascending or descending arm of positive T wave. Biphasic: T wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T waves included). T wave Inversion: T wave which normally points upward in most leads, is seen pointing downward (negative). Normal T wave(-): T amplitude that is negative, without biphasic T wave or notches. Notched T wave(-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T wave. U waves: Presence of abnormal U waves. Number of participants who had any treatment emergent changes of T wave morphology and U-wave presence have been presented. | Up to Day 4 |
| Plasma Concentrations of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of Bepirovirsen. | At 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| Time to Reach Cmax (Tmax) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
| BG002 | Bepirovirsen: Three-Dose SC Injection | Participant received three SC injections of Bepirovirsen dose level 1 on Day 1. |
| BG003 | Placebo: Three SC Injections | Participants received three matching placebo SC injections on Day 1. |
| BG004 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in RR Interval in ECG at Indicated Timepoints | Twelve-lead ECGs were extracted from continuous Holter monitor tracings and RR interval was measured. RR interval is the time duration between the peak of one R wave and the peak of the very next R wave on the ECG. RR interval represents the time between two consecutive heartbeats. ECGs were extracted after a 10 minute supine rest period. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | The analysis was performed on the QT/QTcF set that included all participants in the safety population with a valid CFB QTcF value (measurements at Baseline as well as on treatment with at least 1 post-dose time point). Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Least Squares Mean | 90% Confidence Interval | Milliseconds | Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Secondary | Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints | Continuous 12-lead ECG was captured by Holter monitor. QTcF, PR interval and QRS duration were measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Baseline was defined as pre-dose value on Day 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | QT/QTcF Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Least Squares Mean | 90% Confidence Interval | Milliseconds | Baseline (Pre-dose on Day 1) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Secondary | Number of Participants With Outlier Results for Heart Rate (HR) | Continuous 12-lead ECG was captured by Holter monitor. HR was measured from 10 digital ECGs extracted from the continuous tracing after 10 minutes of rest in supine position. Participants with HR less than (<) 50 beats per minute (bpm) with a decrease of HR greater than (>) 25% and HR >100 bpm with an increase of HR >25% were considered as outlier. | The analysis was performed on the QT/QTcF set that included all participants in the safety population with a valid CFB QTcF value (measurements at Baseline as well as on treatment with at least 1 post-dose time point). | Posted | Count of Participants | Participants | Up to Day 4 |
|
|
|
| Secondary | Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration | Twelve-lead ECG were obtained to measure QTcF interval, PR interval and QRS duration. 12-lead ECG were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Participants with outlier results were determined if the following criteria (which were assessed separately) were met: Participant who had treatment-emergent (TE) value of QTcF>450 and <=480 milliseconds (ms) when not present at Baseline (new onset); TE value of QTcF>480 and <=500 ms when not present at Baseline (new onset); TE value of QTcF>500 ms when not present at Baseline (new onset); increase of QTcF from Baseline of >30 and <=60 ms; increase of QTcF from baseline >60 ms; Increase in PR interval from Baseline >25% resulting in PR >200 ms; increase in QRS duration from Baseline >25% resulting in QRS >120 ms. | The analysis was performed on the QT/QTcF set that included all participants in the safety population with a valid CFB QTcF value (measurements at Baseline as well as on treatment with at least 1 post-dose time point). | Posted | Count of Participants | Participants | Up to Day 4 |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence | Twelve-lead ECG were obtained using an ECG machine. T-wave morphology was categorized as follows: Flat T wave: T amplitude <1 millimeter (mm) (either positive or negative) including flat isoelectric line. Notched T wave(+): Presence of notch(es) of at least 0.05 millivolt(mV) amplitude on ascending or descending arm of positive T wave. Biphasic: T wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T waves included). T wave Inversion: T wave which normally points upward in most leads, is seen pointing downward (negative). Normal T wave(-): T amplitude that is negative, without biphasic T wave or notches. Notched T wave(-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T wave. U waves: Presence of abnormal U waves. Number of participants who had any treatment emergent changes of T wave morphology and U-wave presence have been presented. | The analysis was performed on the QT/QTcF set that included all participants in the safety population with a valid CFB QTcF value (measurements at Baseline as well as on treatment with at least 1 post-dose time point). | Posted | Count of Participants | Participants | Up to Day 4 |
|
|
|
| Secondary | Plasma Concentrations of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of Bepirovirsen. | The analysis was performed on the pharmacokinetic set that included all participants in the Safety Set who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values). Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | 90% Confidence Interval | Nanogram per milliliter (ng/mL) | At 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | Pharmacokinetic Set. Protocol specified AUC(0-inf) could not be calculated due to missing half-life estimates arising from the short period for PK sampling (not enough data points collected for a terminal slope required to calculate AUC[0-infinity]). Area under the concentration-time curve from time zero (0) to time t (AUC[0-t]) has been derived instead, to report exposure up to the last PK sample (72 hours). AUC(0-t) is presented in OM 12. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*Microgram per milliliter (h*ug/mL) | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | The analysis was performed on the pharmacokinetic set that included all participants in the Safety Set who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values) | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*Microgram per milliliter (h*ug/mL) | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | The analysis was performed on the pharmacokinetic set that included all participants in the Safety Set who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values) | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (ug/mL) | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | The analysis was performed on the pharmacokinetic set that included all participants in the Safety Set who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values) | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| Other Pre-specified | AUC(0-t) of Bepirovirsen | Blood samples were collected at the indicated time points for pharmacokinetic analysis of Bepirovirsen. | The analysis was performed on the pharmacokinetic set that included all participants in the Safety Set who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values) | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram per milliliter (h*ug/mL) | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Placebo: Four SC Injections | Participants received four matching placebo SC injections on Day 1. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | Bepirovirsen: Three-Dose SC Injection | Participant received three SC injections of Bepirovirsen dose level 1 on Day 1. | 0 | 18 | 0 | 18 | 15 | 18 |
| EG003 | Placebo: Three SC Injections | Participants received three matching placebo SC injections on Day 1. | 0 | 18 | 0 | 18 | 2 | 18 |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA v28.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v28.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|
| 1 hour |
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| 1.5 hours |
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| 2 hours |
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| 3 hours |
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| 4 hours |
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| 6 hours |
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| 8 hours |
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| 12 hours |
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| 24 hours |
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| 27 hours |
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| 30 hours |
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| 33 hours |
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| 36 hours |
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| 48 hours |
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| 51 hours |
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| 54 hours |
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| 57 hours |
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| 60 hours |
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| 72 hours |
|
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| QTcF Interval, 1 hour |
|
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| QTcF Interval, 1.5 hours |
|
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| QTcF Interval, 2 hours |
|
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| QTcF Interval, 3 hours |
|
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| QTcF Interval, 4 hours |
|
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| QTcF Interval, 6 hours |
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| QTcF Interval, 8 hours |
|
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| QTcF Interval, 12 hours |
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| QTcF Interval, 24 hours |
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| QTcF Interval, 27 hours |
|
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| QTcF Interval, 30 hours |
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| QTcF Interval, 33 hours |
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| QTcF Interval, 36 hours |
|
|
| QTcF Interval, 48 hours |
|
|
| QTcF Interval, 51 hours |
|
|
| QTcF Interval, 54 hours |
|
|
| QTcF Interval, 57 hours |
|
|
| QTcF Interval, 60 hours |
|
|
| QTcF Interval, 72 hours |
|
|
| PR Interval, 0.5 hour |
|
|
| PR Interval, 1 hour |
|
|
| PR Interval, 1.5 hours |
|
|
| PR Interval, 2 hours |
|
|
| PR Interval, 3 hours |
|
|
| PR Interval, 4 hours |
|
|
| PR Interval, 6 hours |
|
|
| PR Interval, 8 hours |
|
|
| PR Interval, 12 hours |
|
|
| PR Interval, 24 hours |
|
|
| PR Interval, 27 hours |
|
|
| PR Interval, 30 hours |
|
|
| PR Interval, 33 hours |
|
|
| PR Interval, 36 hours |
|
|
| PR Interval, 48 hours |
|
|
| PR Interval, 51 hours |
|
|
| PR Interval, 54 hours |
|
|
| PR Interval, 57 hours |
|
|
| PR Interval, 60 hours |
|
|
| PR Interval, 72 hours |
|
|
| QRS Duration, 0.5 hour |
|
|
| QRS Duration, 1 hour |
|
|
| QRS Duration, 1.5 hours |
|
|
| QRS Duration, 2 hours |
|
|
| QRS Duration, 3 hours |
|
|
| QRS Duration, 4 hours |
|
|
| QRS Duration, 6 hours |
|
|
| QRS Duration, 8 hours |
|
|
| QRS Duration, 12 hours |
|
|
| QRS Duration, 24 hours |
|
|
| QRS Duration, 27 hours |
|
|
| QRS Duration, 30 hours |
|
|
| QRS Duration, 33 hours |
|
|
| QRS Duration, 36 hours |
|
|
| QRS Duration, 48 hours |
|
|
| QRS Duration, 51 hours |
|
|
| QRS Duration, 54 hours |
|
|
| QRS Duration, 57 hours |
|
|
| QRS Duration, 60 hours |
|
|
| QRS Duration, 72 hours |
|
|
| HR >100 bpm with an increase of HR >25% |
|
| Total PR interval |
|
| Total QRS duration |
|
| Notched T wave (+) |
|
| Biphasic |
|
| T wave Inversion |
|
| Normal T wave (-) |
|
| Notched T wave (-) |
|
| U waves |
|
| 1 HOUR POST DOSE |
|
|
| 1.5 HOURS POST DOSE |
|
|
| 2 HOURS POST DOSE |
|
|
| 3 HOURS POST DOSE |
|
|
| 4 HOURS POST DOSE |
|
|
| 6 HOURS POST DOSE |
|
|
| 8 HOURS POST DOSE |
|
|
| 12 HOURS POST DOSE |
|
|
| 24 HOURS POST DOSE |
|
|
| 27 HOURS POST DOSE |
|
|
| 30 HOURS POST DOSE |
|
|
| 33 HOURS POST DOSE |
|
|
| 36 HOURS POST DOSE |
|
|
| 48 HOURS POST DOSE |
|
|
| 51 HOURS POST DOSE |
|
|
| 54 HOURS POST DOSE |
|
|
| 57 HOURS POST DOSE |
|
|
| 60 HOURS POST DOSE |
|
|
| 72 HOURS POST DOSE |
|
|