Trial Outcomes & Findings for Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers (NCT NCT06422767)

Last Updated: 2026-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

Baseline (Pre-dose on Day 1) and Day 4

Results posted on

2026-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Bepirovirsen: Four-Dose SC Injection Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Four SC Injections Participants received four matching placebo SC injections on Day 1.	Bepirovirsen: Three-Dose SC Injection Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections Participants received three matching placebo SC injections on Day 1.
Overall Study STARTED	5	5	18	18
Overall Study COMPLETED	5	5	18	18
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Four SC Injections n=5 Participants Participants received four matching placebo SC injections on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.	Total n=46 Participants Total of all reporting groups
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	0 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=267 Participants	1 Participants n=265 Participants	2 Participants n=568 Participants
Age, Continuous	31.4 YEARS STANDARD_DEVIATION 11.24 • n=9 Participants	33.2 YEARS STANDARD_DEVIATION 4.02 • n=27 Participants	39.4 YEARS STANDARD_DEVIATION 7.96 • n=267 Participants	38.6 YEARS STANDARD_DEVIATION 10.29 • n=265 Participants	37.5 YEARS STANDARD_DEVIATION 9.20 • n=568 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	2 Participants n=27 Participants	10 Participants n=267 Participants	4 Participants n=265 Participants	19 Participants n=568 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	3 Participants n=27 Participants	8 Participants n=267 Participants	14 Participants n=265 Participants	27 Participants n=568 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	1 Participants n=9 Participants	3 Participants n=27 Participants	5 Participants n=267 Participants	6 Participants n=265 Participants	15 Participants n=568 Participants
Race/Ethnicity, Customized MULTIPLE	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants
Race/Ethnicity, Customized WHITE	3 Participants n=9 Participants	2 Participants n=27 Participants	12 Participants n=267 Participants	11 Participants n=265 Participants	28 Participants n=568 Participants

PRIMARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Day 4

Population: 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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections Participants received three matching placebo SC injections on Day 1.
Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose	2.360 Milliseconds Interval -0.249 to 4.97	2.024 Milliseconds Interval -0.541 to 4.589	—	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=5 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.
Change From Baseline in RR Interval in ECG at Indicated Timepoints 0.5 hour	-7.95 Milliseconds Interval -60.63 to 44.73	14.72 Milliseconds Interval -38.17 to 67.61	19.13 Milliseconds Interval -8.63 to 46.89	-0.93 Milliseconds Interval -28.74 to 26.87
Change From Baseline in RR Interval in ECG at Indicated Timepoints 1 hour	3.67 Milliseconds Interval -53.42 to 60.75	50.71 Milliseconds Interval -6.57 to 107.99	18.03 Milliseconds Interval -12.06 to 48.11	9.71 Milliseconds Interval -20.42 to 39.83
Change From Baseline in RR Interval in ECG at Indicated Timepoints 6 hours	-120.71 Milliseconds Interval -184.84 to -56.58	-103.76 Milliseconds Interval -168.07 to -39.45	-99.72 Milliseconds Interval -133.52 to -65.91	-90.71 Milliseconds Interval -124.55 to -56.88
Change From Baseline in RR Interval in ECG at Indicated Timepoints 24 hours	-210.04 Milliseconds Interval -294.47 to -125.6	54.73 Milliseconds Interval -29.99 to 139.46	-174.72 Milliseconds Interval -219.22 to -130.22	-13.12 Milliseconds Interval -57.68 to 31.44
Change From Baseline in RR Interval in ECG at Indicated Timepoints 30 hours	-268.76 Milliseconds Interval -339.8 to -197.71	-75.22 Milliseconds Interval -146.61 to -3.83	-252.77 Milliseconds Interval -290.22 to -215.33	-67.37 Milliseconds Interval -104.88 to -29.86
Change From Baseline in RR Interval in ECG at Indicated Timepoints 33 hours	-309.66 Milliseconds Interval -407.15 to -212.17	0.43 Milliseconds Interval -97.32 to 98.17	-228.07 Milliseconds Interval -279.46 to -176.69	-5.83 Milliseconds Interval -57.26 to 45.6
Change From Baseline in RR Interval in ECG at Indicated Timepoints 1.5 hours	39.14 Milliseconds Interval -11.08 to 89.37	56.68 Milliseconds Interval 6.23 to 107.13	44.65 Milliseconds Interval 18.18 to 71.12	20.93 Milliseconds Interval -5.59 to 47.44
Change From Baseline in RR Interval in ECG at Indicated Timepoints 2 hours	43.01 Milliseconds Interval -17.2 to 103.21	76.33 Milliseconds Interval 15.94 to 136.72	16.36 Milliseconds Interval -15.37 to 48.09	-23.26 Milliseconds Interval -55.03 to 8.5
Change From Baseline in RR Interval in ECG at Indicated Timepoints 3 hours	16.12 Milliseconds Interval -44.35 to 76.58	14.63 Milliseconds Interval -46.03 to 75.28	24.20 Milliseconds Interval -7.67 to 56.07	41.34 Milliseconds Interval 9.44 to 73.25
Change From Baseline in RR Interval in ECG at Indicated Timepoints 4 hours	40.29 Milliseconds Interval -20.16 to 100.74	20.71 Milliseconds Interval -39.92 to 81.35	8.19 Milliseconds Interval -23.67 to 40.05	7.28 Milliseconds Interval -24.61 to 39.18
Change From Baseline in RR Interval in ECG at Indicated Timepoints 8 hours	-107.52 Milliseconds Interval -175.79 to -39.25	-61.77 Milliseconds Interval -130.2 to 6.66	-47.28 Milliseconds Interval -83.26 to -11.3	-12.65 Milliseconds Interval -48.66 to 23.37
Change From Baseline in RR Interval in ECG at Indicated Timepoints 12 hours	-156.23 Milliseconds Interval -221.65 to -90.81	-30.05 Milliseconds Interval -95.63 to 35.54	-94.03 Milliseconds Interval -128.5 to -59.55	-14.46 Milliseconds Interval -48.97 to 20.06
Change From Baseline in RR Interval in ECG at Indicated Timepoints 27 hours	-215.57 Milliseconds Interval -295.41 to -135.73	14.16 Milliseconds Interval -65.98 to 94.31	-235.20 Milliseconds Interval -277.28 to -193.13	-59.80 Milliseconds Interval -101.94 to -17.66
Change From Baseline in RR Interval in ECG at Indicated Timepoints 36 hours	-277.56 Milliseconds Interval -358.5 to -196.61	-33.61 Milliseconds Interval -114.86 to 47.64	-216.23 Milliseconds Interval -258.89 to -173.57	-53.15 Milliseconds Interval -95.87 to -10.42
Change From Baseline in RR Interval in ECG at Indicated Timepoints 48 hours	-159.48 Milliseconds Interval -228.56 to -90.41	-20.07 Milliseconds Interval -89.45 to 49.31	-92.84 Milliseconds Interval -129.57 to -56.12	-33.32 Milliseconds Interval -69.76 to 3.12
Change From Baseline in RR Interval in ECG at Indicated Timepoints 51 hours	-149.11 Milliseconds Interval -211.3 to -86.91	-74.51 Milliseconds Interval -132.04 to -16.98	-95.92 Milliseconds Interval -126.04 to -65.79	-75.97 Milliseconds Interval -106.13 to -45.8
Change From Baseline in RR Interval in ECG at Indicated Timepoints 54 hours	-132.04 Milliseconds Interval -194.49 to -69.58	-75.43 Milliseconds Interval -136.06 to -14.79	-146.19 Milliseconds Interval -177.96 to -114.42	-70.96 Milliseconds Interval -102.77 to -39.15
Change From Baseline in RR Interval in ECG at Indicated Timepoints 57 hours	-128.59 Milliseconds Interval -207.53 to -49.64	-54.79 Milliseconds Interval -134.01 to 24.42	-86.77 Milliseconds Interval -128.38 to -45.16	-17.29 Milliseconds Interval -58.93 to 24.35
Change From Baseline in RR Interval in ECG at Indicated Timepoints 60 hours	-150.79 Milliseconds Interval -211.22 to -90.36	-92.73 Milliseconds Interval -153.51 to -31.94	-110.61 Milliseconds Interval -142.47 to -78.76	-92.98 Milliseconds Interval -124.87 to -61.09
Change From Baseline in RR Interval in ECG at Indicated Timepoints 72 hours	-29.90 Milliseconds Interval -95.84 to 36.04	-36.70 Milliseconds Interval -103.2 to 29.8	-70.02 Milliseconds Interval -105.79 to -34.26	-70.07 Milliseconds Interval -104.89 to -35.26

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=5 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 3 hours	-1.92 Milliseconds Interval -5.77 to 1.94	3.44 Milliseconds Interval -0.41 to 7.28	-0.30 Milliseconds Interval -2.36 to 1.75	-4.04 Milliseconds Interval -6.08 to -1.99
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 24 hours	-10.46 Milliseconds Interval -16.96 to -3.96	0.99 Milliseconds Interval -5.47 to 7.45	-14.35 Milliseconds Interval -17.85 to -10.85	-10.12 Milliseconds Interval -13.58 to -6.65
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 51 hours	-9.06 Milliseconds Interval -15.38 to -2.74	-6.68 Milliseconds Interval -12.3 to -1.05	-7.48 Milliseconds Interval -10.52 to -4.44	-11.75 Milliseconds Interval -14.77 to -8.74
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 54 hours	-4.72 Milliseconds Interval -10.72 to 1.28	-2.33 Milliseconds Interval -8.06 to 3.4	-9.56 Milliseconds Interval -12.65 to -6.46	-11.74 Milliseconds Interval -14.81 to -8.67
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 4 hours	2.73 Milliseconds Interval -2.27 to 7.74	3.63 Milliseconds Interval -1.35 to 8.62	-0.45 Milliseconds Interval -3.07 to 2.18	-0.29 Milliseconds Interval -2.92 to 2.33
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 6 hours	-1.80 Milliseconds Interval -6.09 to 2.48	-4.24 Milliseconds Interval -8.5 to 0.02	-3.34 Milliseconds Interval -5.59 to -1.1	-2.44 Milliseconds Interval -4.69 to -0.19
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 12 hours	-1.67 Milliseconds Interval -6.33 to 2.99	-2.57 Milliseconds Interval -7.22 to 2.07	-2.18 Milliseconds Interval -4.62 to 0.27	-0.46 Milliseconds Interval -2.91 to 1.99
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 48 hours	-0.84 Milliseconds Interval -4.96 to 3.29	0.04 Milliseconds Interval -4.03 to 4.12	-0.29 Milliseconds Interval -2.48 to 1.89	0.34 Milliseconds Interval -1.81 to 2.49
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 54 hours	0.34 Milliseconds Interval -3.95 to 4.64	-5.69 Milliseconds Interval -9.68 to -1.7	-3.89 Milliseconds Interval -5.99 to -1.79	-2.53 Milliseconds Interval -4.64 to -0.42
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 57 hours	-1.37 Milliseconds Interval -5.83 to 3.1	-2.16 Milliseconds Interval -6.58 to 2.26	-2.66 Milliseconds Interval -4.99 to -0.34	-0.52 Milliseconds Interval -2.85 to 1.81
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 51 hours	-1.13 Milliseconds Interval -2.71 to 0.45	0.02 Milliseconds Interval -1.38 to 1.41	0.56 Milliseconds Interval -0.18 to 1.3	-0.04 Milliseconds Interval -0.78 to 0.7
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 51 hours	6.31 Milliseconds Interval 1.79 to 10.84	-2.49 Milliseconds Interval -6.3 to 1.31	-1.33 Milliseconds Interval -3.33 to 0.67	-1.50 Milliseconds Interval -3.51 to 0.51
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 60 hours	1.70 Milliseconds Interval -3.91 to 7.3	-2.20 Milliseconds Interval -7.76 to 3.37	-0.59 Milliseconds Interval -3.52 to 2.34	0.42 Milliseconds Interval -2.52 to 3.35
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 72 hours	1.29 Milliseconds Interval -3.74 to 6.31	0.26 Milliseconds Interval -4.67 to 5.19	1.20 Milliseconds Interval -1.46 to 3.87	1.84 Milliseconds Interval -0.76 to 4.45
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 0.5 hour	0.09 Milliseconds Interval -0.9 to 1.09	0.21 Milliseconds Interval -0.78 to 1.2	-0.39 Milliseconds Interval -0.92 to 0.13	-0.03 Milliseconds Interval -0.55 to 0.49
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 1 hour	0.12 Milliseconds Interval -1.07 to 1.32	-0.06 Milliseconds Interval -1.25 to 1.13	-0.73 Milliseconds Interval -1.36 to -0.1	-0.03 Milliseconds Interval -0.66 to 0.6
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 1.5 hours	0.06 Milliseconds Interval -0.78 to 0.9	-0.15 Milliseconds Interval -0.98 to 0.69	0.17 Milliseconds Interval -0.27 to 0.61	-0.20 Milliseconds Interval -0.64 to 0.24
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 2 hours	-0.28 Milliseconds Interval -1.28 to 0.73	-0.19 Milliseconds Interval -1.19 to 0.81	0.40 Milliseconds Interval -0.13 to 0.93	-0.11 Milliseconds Interval -0.63 to 0.42
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 3 hours	-0.74 Milliseconds Interval -1.6 to 0.11	0.44 Milliseconds Interval -0.41 to 1.29	-0.33 Milliseconds Interval -0.77 to 0.12	-0.24 Milliseconds Interval -0.68 to 0.21
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 4 hours	-0.68 Milliseconds Interval -2.07 to 0.72	0.72 Milliseconds Interval -0.68 to 2.11	-0.31 Milliseconds Interval -1.05 to 0.42	0.53 Milliseconds Interval -0.2 to 1.27
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 6 hours	-0.54 Milliseconds Interval -1.54 to 0.45	0.21 Milliseconds Interval -0.78 to 1.2	-0.27 Milliseconds Interval -0.79 to 0.26	-0.37 Milliseconds Interval -0.89 to 0.15
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 8 hours	-0.01 Milliseconds Interval -1.21 to 1.19	1.61 Milliseconds Interval 0.42 to 2.8	0.16 Milliseconds Interval -0.47 to 0.79	-0.70 Milliseconds Interval -1.33 to -0.07
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 12 hours	-0.74 Milliseconds Interval -1.94 to 0.45	0.81 Milliseconds Interval -0.38 to 2.0	0.02 Milliseconds Interval -0.61 to 0.65	-0.33 Milliseconds Interval -0.96 to 0.3
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 24 hours	-1.08 Milliseconds Interval -2.34 to 0.18	-0.25 Milliseconds Interval -1.5 to 0.99	0.09 Milliseconds Interval -0.58 to 0.75	0.11 Milliseconds Interval -0.54 to 0.77
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 27 hours	-1.15 Milliseconds Interval -2.45 to 0.15	0.55 Milliseconds Interval -0.74 to 1.84	-0.18 Milliseconds Interval -0.86 to 0.51	-0.73 Milliseconds Interval -1.41 to -0.05
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 30 hours	-0.38 Milliseconds Interval -1.87 to 1.11	0.55 Milliseconds Interval -0.93 to 2.02	0.05 Milliseconds Interval -0.73 to 0.84	-1.24 Milliseconds Interval -2.02 to -0.46
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 33 hours	-1.22 Milliseconds Interval -2.73 to 0.29	1.35 Milliseconds Interval -0.15 to 2.84	0.63 Milliseconds Interval -0.17 to 1.42	-0.51 Milliseconds Interval -1.31 to 0.28
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 36 hours	-1.48 Milliseconds Interval -3.18 to 0.21	-0.25 Milliseconds Interval -1.94 to 1.43	0.34 Milliseconds Interval -0.55 to 1.23	-0.15 Milliseconds Interval -1.04 to 0.73
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 48 hours	-0.97 Milliseconds Interval -2.57 to 0.63	-0.18 Milliseconds Interval -1.77 to 1.4	0.46 Milliseconds Interval -0.4 to 1.31	-0.19 Milliseconds Interval -1.02 to 0.65
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 1 hour	-0.99 Milliseconds Interval -4.04 to 2.06	-1.85 Milliseconds Interval -4.89 to 1.18	-0.87 Milliseconds Interval -2.51 to 0.76	-3.85 Milliseconds Interval -5.47 to -2.22
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 54 hours	-1.51 Milliseconds Interval -3.14 to 0.12	0.08 Milliseconds Interval -1.46 to 1.62	0.50 Milliseconds Interval -0.31 to 1.32	-0.98 Milliseconds Interval -1.8 to -0.17
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 0.5 hour	-2.75 Milliseconds Interval -6.22 to 0.71	-1.80 Milliseconds Interval -5.25 to 1.65	-0.84 Milliseconds Interval -2.69 to 1.01	-3.00 Milliseconds Interval -4.84 to -1.16
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 57 hours	0.16 Milliseconds Interval -1.19 to 1.51	1.15 Milliseconds Interval -0.19 to 2.49	0.84 Milliseconds Interval 0.13 to 1.55	0.35 Milliseconds Interval -0.35 to 1.06
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 1.5 hours	0.03 Milliseconds Interval -4.1 to 4.17	-0.94 Milliseconds Interval -5.06 to 3.18	0.14 Milliseconds Interval -2.06 to 2.34	-2.19 Milliseconds Interval -4.38 to 0.0
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 2 hours	1.09 Milliseconds Interval -2.02 to 4.19	-0.95 Milliseconds Interval -4.05 to 2.14	-0.15 Milliseconds Interval -1.82 to 1.51	-3.75 Milliseconds Interval -5.41 to -2.1
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 4 hours	-1.25 Milliseconds Interval -5.57 to 3.08	2.93 Milliseconds Interval -1.39 to 7.24	0.25 Milliseconds Interval -2.05 to 2.55	-2.57 Milliseconds Interval -4.87 to -0.28
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 60 hours	0.43 Milliseconds Interval -1.18 to 2.03	0.96 Milliseconds Interval -0.63 to 2.55	0.75 Milliseconds Interval -0.1 to 1.59	-0.02 Milliseconds Interval -0.86 to 0.82
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 6 hours	-5.97 Milliseconds Interval -11.62 to -0.33	-3.67 Milliseconds Interval -9.31 to 1.97	-9.00 Milliseconds Interval -11.99 to -6.01	-9.68 Milliseconds Interval -12.67 to -6.7
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QRS Duration, 72 hours	-0.50 Milliseconds Interval -2.89 to 1.88	0.42 Milliseconds Interval -1.92 to 2.77	0.44 Milliseconds Interval -0.85 to 1.73	0.34 Milliseconds Interval -0.9 to 1.58
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 8 hours	-7.22 Milliseconds Interval -12.81 to -1.63	-2.42 Milliseconds Interval -8.0 to 3.16	-8.68 Milliseconds Interval -11.64 to -5.72	-10.65 Milliseconds Interval -13.61 to -7.7
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 12 hours	-6.19 Milliseconds Interval -12.49 to 0.11	-1.19 Milliseconds Interval -7.49 to 5.1	-10.16 Milliseconds Interval -13.49 to -6.82	-9.25 Milliseconds Interval -12.58 to -5.93
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 27 hours	-15.45 Milliseconds Interval -24.33 to -6.57	-5.24 Milliseconds Interval -14.09 to 3.62	-17.87 Milliseconds Interval -22.6 to -13.13	-10.81 Milliseconds Interval -15.52 to -6.1
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 33 hours	-15.32 Milliseconds Interval -23.62 to -7.02	-1.35 Milliseconds Interval -9.62 to 6.92	-8.72 Milliseconds Interval -13.15 to -4.29	-3.01 Milliseconds Interval -7.42 to 1.4
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 30 hours	-15.92 Milliseconds Interval -24.91 to -6.92	-1.10 Milliseconds Interval -10.07 to 7.87	-16.62 Milliseconds Interval -21.41 to -11.83	-9.23 Milliseconds Interval -14.0 to -4.45
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 36 hours	-10.69 Milliseconds Interval -18.14 to -3.25	-2.31 Milliseconds Interval -9.72 to 5.11	-10.65 Milliseconds Interval -14.63 to -6.66	-5.38 Milliseconds Interval -9.34 to -1.41
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 48 hours	-5.10 Milliseconds Interval -11.25 to 1.05	2.26 Milliseconds Interval -3.86 to 8.38	-3.69 Milliseconds Interval -7.02 to -0.36	-6.20 Milliseconds Interval -9.47 to -2.93
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 57 hours	-6.08 Milliseconds Interval -12.97 to 0.81	0.25 Milliseconds Interval -6.62 to 7.11	-4.65 Milliseconds Interval -8.33 to -0.97	-5.95 Milliseconds Interval -9.61 to -2.29
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 60 hours	-11.87 Milliseconds Interval -17.97 to -5.78	-1.28 Milliseconds Interval -7.35 to 4.79	-7.83 Milliseconds Interval -11.1 to -4.56	-7.81 Milliseconds Interval -11.06 to -4.56
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints QTcF Interval, 72 hours	-1.43 Milliseconds Interval -7.18 to 4.31	1.50 Milliseconds Interval -4.19 to 7.2	-5.20 Milliseconds Interval -8.43 to -1.98	-7.64 Milliseconds Interval -10.72 to -4.55
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 0.5 hour	-1.94 Milliseconds Interval -5.1 to 1.23	-1.17 Milliseconds Interval -4.31 to 1.96	0.57 Milliseconds Interval -1.07 to 2.22	0.00 Milliseconds Interval -1.65 to 1.65
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 1 hour	0.20 Milliseconds Interval -3.27 to 3.66	4.96 Milliseconds Interval 1.52 to 8.4	1.67 Milliseconds Interval -0.14 to 3.48	-0.59 Milliseconds Interval -2.41 to 1.22
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 1.5 hours	-0.00 Milliseconds Interval -3.39 to 3.39	-3.49 Milliseconds Interval -6.85 to -0.12	0.75 Milliseconds Interval -1.02 to 2.52	-0.07 Milliseconds Interval -1.85 to 1.7
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 2 hours	-0.80 Milliseconds Interval -4.0 to 2.4	-1.77 Milliseconds Interval -4.94 to 1.39	0.52 Milliseconds Interval -1.15 to 2.18	-0.83 Milliseconds Interval -2.5 to 0.84
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 3 hours	-2.34 Milliseconds Interval -6.86 to 2.18	-1.33 Milliseconds Interval -5.83 to 3.17	0.39 Milliseconds Interval -1.98 to 2.76	0.11 Milliseconds Interval -2.26 to 2.49
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 8 hours	-5.47 Milliseconds Interval -10.49 to -0.45	-3.41 Milliseconds Interval -8.41 to 1.6	-7.85 Milliseconds Interval -10.49 to -5.22	-4.54 Milliseconds Interval -7.17 to -1.9
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 24 hours	-0.40 Milliseconds Interval -5.36 to 4.56	2.15 Milliseconds Interval -2.75 to 7.05	-3.58 Milliseconds Interval -6.16 to -1.01	0.99 Milliseconds Interval -1.6 to 3.58
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 27 hours	-3.93 Milliseconds Interval -8.69 to 0.82	-4.18 Milliseconds Interval -8.88 to 0.52	-4.65 Milliseconds Interval -7.12 to -2.18	-0.22 Milliseconds Interval -2.7 to 2.26
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 30 hours	-3.64 Milliseconds Interval -9.16 to 1.88	-4.58 Milliseconds Interval -10.05 to 0.89	-3.85 Milliseconds Interval -6.72 to -0.97	-1.75 Milliseconds Interval -4.64 to 1.13
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 33 hours	-0.69 Milliseconds Interval -6.17 to 4.79	-2.31 Milliseconds Interval -7.74 to 3.11	-5.69 Milliseconds Interval -8.54 to -2.83	0.72 Milliseconds Interval -2.15 to 3.58
Change From Baseline in QTcF Interval, PR Interval and QRS Duration at Indicated Timepoints PR Interval, 36 hours	-3.60 Milliseconds Interval -10.13 to 2.93	-1.71 Milliseconds Interval -8.2 to 4.78	-3.07 Milliseconds Interval -6.48 to 0.35	0.97 Milliseconds Interval -2.45 to 4.39

SECONDARY outcome

Timeframe: Up to Day 4

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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=5 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.
Number of Participants With Outlier Results for Heart Rate (HR) HR >100 bpm with an increase of HR >25%	3 Participants	0 Participants	8 Participants	0 Participants
Number of Participants With Outlier Results for Heart Rate (HR) HR <50 bpm with a decrease of HR >25%	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 4

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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=5 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.
Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration Total QTcF interval	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration Total PR interval	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Outlier Results for Total QTcF Interval, PR Interval and QRS Duration Total QRS duration	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 4

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.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=5 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections n=18 Participants Participants received three matching placebo SC injections on Day 1.
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence Flat T wave	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence Notched T wave (+)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence Biphasic	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence T wave Inversion	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence Normal T wave (-)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence Notched T wave (-)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Changes of T Wave Morphology and U-wave Presence U waves	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of Bepirovirsen.

Outcome measures

Outcome measures
Measure	Bepirovirsen: Four-Dose SC Injection n=5 Participants Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection n=18 Participants Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Bepirovirsen: Three-Dose SC Injection Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.	Placebo: Three SC Injections Participants received three matching placebo SC injections on Day 1.
Plasma Concentrations of Bepirovirsen 27 HOURS POST DOSE	893.400 Nanogram per milliliter (ng/mL) Interval 543.042 to 1243.758	630.000 Nanogram per milliliter (ng/mL) Interval 359.829 to 900.171	—	—
Plasma Concentrations of Bepirovirsen 30 HOURS POST DOSE	618.400 Nanogram per milliliter (ng/mL) Interval 444.789 to 792.011	361.612 Nanogram per milliliter (ng/mL) Interval 218.487 to 504.737	—	—
Plasma Concentrations of Bepirovirsen 33 HOURS POST DOSE	357.600 Nanogram per milliliter (ng/mL) Interval 271.666 to 443.534	245.383 Nanogram per milliliter (ng/mL) Interval 118.524 to 372.243	—	—
Plasma Concentrations of Bepirovirsen 36 HOURS POST DOSE	227.600 Nanogram per milliliter (ng/mL) Interval 199.113 to 256.087	160.429 Nanogram per milliliter (ng/mL) Interval 82.066 to 238.793	—	—
Plasma Concentrations of Bepirovirsen 48 HOURS POST DOSE	84.220 Nanogram per milliliter (ng/mL) Interval 64.387 to 104.053	64.194 Nanogram per milliliter (ng/mL) Interval 35.668 to 92.721	—	—
Plasma Concentrations of Bepirovirsen 51 HOURS POST DOSE	70.060 Nanogram per milliliter (ng/mL) Interval 50.72 to 89.4	46.100 Nanogram per milliliter (ng/mL) Interval 30.05 to 62.15	—	—
Plasma Concentrations of Bepirovirsen 54 HOURS POST DOSE	62.960 Nanogram per milliliter (ng/mL) Interval 44.833 to 81.087	33.833 Nanogram per milliliter (ng/mL) Interval 24.425 to 43.242	—	—
Plasma Concentrations of Bepirovirsen 57 HOURS POST DOSE	49.800 Nanogram per milliliter (ng/mL) Interval 33.689 to 65.911	29.844 Nanogram per milliliter (ng/mL) Interval 23.858 to 35.831	—	—
Plasma Concentrations of Bepirovirsen 60 HOURS POST DOSE	44.300 Nanogram per milliliter (ng/mL) Interval 30.819 to 57.781	25.978 Nanogram per milliliter (ng/mL) Interval 21.367 to 30.588	—	—
Plasma Concentrations of Bepirovirsen 72 HOURS POST DOSE	32.500 Nanogram per milliliter (ng/mL) Interval 21.637 to 43.363	20.344 Nanogram per milliliter (ng/mL) Interval 17.238 to 23.449	—	—
Plasma Concentrations of Bepirovirsen 4 HOURS POST DOSE	16696.000 Nanogram per milliliter (ng/mL) Interval 11867.748 to 21524.252	15061.111 Nanogram per milliliter (ng/mL) Interval 13733.795 to 16388.428	—	—
Plasma Concentrations of Bepirovirsen 6 HOURS POST DOSE	15210.000 Nanogram per milliliter (ng/mL) Interval 9582.53 to 20837.47	13112.778 Nanogram per milliliter (ng/mL) Interval 11896.945 to 14328.61	—	—
Plasma Concentrations of Bepirovirsen 8 HOURS POST DOSE	12580.000 Nanogram per milliliter (ng/mL) Interval 9399.759 to 15760.241	11667.222 Nanogram per milliliter (ng/mL) Interval 10398.191 to 12936.254	—	—
Plasma Concentrations of Bepirovirsen 12 HOURS POST DOSE	11438.000 Nanogram per milliliter (ng/mL) Interval 7101.673 to 15774.327	8303.750 Nanogram per milliliter (ng/mL) Interval 6989.831 to 9617.669	—	—
Plasma Concentrations of Bepirovirsen 24 HOURS POST DOSE	1485.250 Nanogram per milliliter (ng/mL) Interval 132.388 to 2838.112	1101.286 Nanogram per milliliter (ng/mL) Interval 598.829 to 1603.743	—	—
Plasma Concentrations of Bepirovirsen 1 HOUR POST DOSE	9054.000 Nanogram per milliliter (ng/mL) Interval 4466.537 to 13641.463	7749.444 Nanogram per milliliter (ng/mL) Interval 5084.232 to 10414.657	—	—
Plasma Concentrations of Bepirovirsen 1.5 HOURS POST DOSE	12842.000 Nanogram per milliliter (ng/mL) Interval 6817.104 to 18866.896	10185.294 Nanogram per milliliter (ng/mL) Interval 8036.832 to 12333.756	—	—
Plasma Concentrations of Bepirovirsen 2 HOURS POST DOSE	14048.000 Nanogram per milliliter (ng/mL) Interval 9182.574 to 18913.426	12137.500 Nanogram per milliliter (ng/mL) Interval 10047.899 to 14227.101	—	—
Plasma Concentrations of Bepirovirsen 3 HOURS POST DOSE	16152.000 Nanogram per milliliter (ng/mL) Interval 10647.167 to 21656.833	14115.882 Nanogram per milliliter (ng/mL) Interval 12298.053 to 15933.712	—	—
Plasma Concentrations of Bepirovirsen 0.5 HOUR POST DOSE	4200.000 Nanogram per milliliter (ng/mL) Interval 1646.754 to 6753.246	4609.529 Nanogram per milliliter (ng/mL) Interval 964.519 to 8254.539	—	—

SECONDARY outcome

Timeframe: 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

Population: 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.