Study of VIR-3434 in Healthy Volunteers and Patients With... | NCT04423393

ID	Type	Description	Link
2019-003837-40	EudraCT Number

Study of VIR-3434 in Healthy Volunteers and Patients With... | NCT04423393 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
VIR-3434	Experimental		Biological: VIR-3434
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
VIR-3434	Biological	VIR-3434 given by subcutaneous injection or intravenous infusion.	VIR-3434

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)		Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities		Up to 280 days post-dose

Secondary Outcomes

Measure	Description	Time Frame
Cmax	VIR-3434 Maximum Concentration in Serum	Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Tmax	VIR-3434 time of Cmax in Serum

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site		Essen		45147	Germany
Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40882923	Derived	Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2026 Jan;84(1):62-73. doi: 10.1016/j.jhep.2025.08.016. Epub 2025 Aug 27.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
FG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 20, 2022	Oct 20, 2023

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0051 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0110 subjects FG0120 subjects FG0131 subjects FG0140 subjects FG0150 subjects FG0160 subjects FG0170 subjects
Sponsor Decision		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
BG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
BG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
BG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
BG004	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously
BG005	Part A Healthy Participants Placebo	Healthy participants received placebo subcutaneously or intravenously
BG006	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
BG007	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous
BG008	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous
BG009	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous
BG010	Part B: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received placebo subcutaneous
BG011	Part C: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg >/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
BG012	Part C: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
BG013	Part C: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
BG014	Part C: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received placebo subcutaneous
BG015	Part D: HBV Participants 75 mg SC	HBV Participants not on NRTI therapy with HBV DNA >/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
BG016	Part D: HBV Participants 300 mg SC	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
BG017	Part D: HBV Participants Placebo	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
BG018	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG0006 ParticipantsBG0016 ParticipantsBG0026 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0006 ParticipantsBG0016 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0006 ParticipantsBG0016 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0006 ParticipantsBG0016 ParticipantsBG002

Baseline HbsAg (IU/mL)

HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.

Mean

Standard Deviation

log 10 IU/mL

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

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

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Posted

Count of Participants

Participants

Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously
OG005	Part A Healthy Participants Placebo	Healthy participants received placebo subcutaneously or intravenously
OG006	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG007	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous
OG008	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous
OG009	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous
OG010	Part B: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received placebo subcutaneous
OG011	Part C: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg >/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
OG012	Part C: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
OG013	Part C: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
OG014	Part C: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received placebo subcutaneous
OG015	Part D: HBV Participants 75 mg SC	HBV Participants not on NRTI therapy with HBV DNA >/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
OG016	Part D: HBV Participants 300 mg SC	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
OG017	Part D: HBV Participants Placebo	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 IU/mL and any HBsAg level received placebo subcutaneous

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0014 OG0025 OG003

Primary

Number of Participants With Clinical Laboratory Abnormalities

Posted

Count of Participants

Participants

Up to 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously
OG005

Secondary

Cmax

VIR-3434 Maximum Concentration in Serum

PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

Parts B-D: ng/mL

Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG001	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous
OG002	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous
OG003	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous
OG004

Secondary

Tmax

VIR-3434 time of Cmax in Serum

Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. CV was only calculated if the PK parameter was estimated in at least 3 subjects

Posted

Median

Full Range

day

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously

Secondary

AUClast

VIR-3434 under the curve from time 0 to last measurable Time

Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts.

Posted

Geometric Mean

Geometric Coefficient of Variation

Parts B-D: day*ng/mL

Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG001	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous
OG002	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous
OG003	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous

Secondary

t1/2

VIR-3434 apparent Elimination Half-life (t1/2) in serum

PK Anal;ysis Set

Posted

Median

Full Range

day

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV

Secondary

Vz/F

VIR-3434 Volume of Distribution (SC only)

PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG004

Secondary

VIR-3434 Volume of Distribution (IV only)

Posted

Geometric Mean

Geometric Coefficient of Variation

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

ID	Title	Description
OG000	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG001	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously

Units	Counts
Participants	OG000

Secondary

CL/F

VIR-3434 Apparent serum clearance (SC only)

PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG004

Secondary

VIR-3434 Apparent serum clearance (IV only)

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/day

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

ID	Title	Description
OG000	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG001	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously

Units	Counts
Participants	OG000

Secondary

Number of Participants With ADA to VIR-3434

Evaluate the immunogenicity of VIR-3434

Immunogenicity Analysis Set

Posted

Number

Participants

Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV

Secondary

Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)

HBsAg reductions at nadir and Week 4

Posted

Mean

Standard Deviation

IU/mL

Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous
OG001	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous
OG002	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous
OG003	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous
OG004	Part B: HBV Participants Placebo

Secondary

Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)

HBV DNA reductions at nadir and Week 4

Posted

Mean

Standard Deviation

IU/mL

Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose

ID	Title	Description
OG000	Part D: HBV Participants 75 mg SC	HBV Participants not on NRTI therapy with HBV DNA >/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
OG001	Part D: HBV Participants 300 mg SC	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
OG002	Part D: HBV Participants Placebo	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 IU/mL and any HBsAg level received placebo subcutaneous

Units	Counts
Participants

Secondary

Titers (if Applicable) of ADA to VIR-3434

Evaluate the immunogenicity of VIR-3434

Immunogenicity Analysis Set

Posted

Median

Full Range

Median Titer

Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV

Secondary

Cmax

VIR-3434 Maximum Concentration in Serum

PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

Part A: μg/mL

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously
OG004	Part A: Healthy Participants 3000 mg IV

Secondary

AUClast

VIR-3434 under the curve from time 0 to last measurable Time

Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. AUClast was only calculated if the PK parameter was estimated in at least 3 subjects

Posted

Geometric Mean

Geometric Coefficient of Variation

Part A: day*µg/mL

Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose

ID	Title	Description
OG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous
OG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous
OG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous
OG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Healthy Participants 90 mg SC	Healthy participants received 90 mg VIR-3434 subcutaneous	6	0	6	4	6
EG001	Part A Healthy Participants 300 mg SC	Healthy participants received 300 mg VIR-3434 subcutaneous	6	0	6	4	6
EG002	Part A Healthy Participants 900 mg SC	Healthy participants received 900 mg VIR-3434 subcutaneous	6	0	6	5	6
EG003	Part A Healthy Participants 900 mg IV	Healthy Participants received 900 mg VIR-3434 intravenously	6	0	6	4	6
EG004	Part A: Healthy Participants 3000 mg IV	Healthy participants received 3000 mg VIR-3434 intravenously	6	0	6	3	6
EG005	Part A Healthy Participants Placebo	Healthy participants received placebo subcutaneously or intravenously	11	0	11	6	11
EG006	Part B: HBV Participants 6 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 6 mg VIR-3434 subcutaneous	6	0	6	0	6
EG007	Part B: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg <3000 IU/mL received 18 mg VIR-3434 subcutaneous	6	0	6	1	6
EG008	Part B: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 75 mg VIR-3434 subcutaneous	6	0	6	2	6
EG009	Part B: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received 300 mg VIR-3434 subcutaneous	6	0	6	3	6
EG010	Part B: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg <3000 IU/mL received placebo subcutaneous	8	0	8	2	8
EG011	Part C: HBV Participants 18 mg SC	HBV Participants on NRTI therapy with HBsAg >/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous	6	0	6	2	6
EG012	Part C: HBV Participants 75 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous	6	0	6	4	6
EG013	Part C: HBV Participants 300 mg SC	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous	6	1	6	5	6
EG014	Part C: HBV Participants Placebo	HBV Participants on NRTI Therapy with HBsAg >/= 3000 IU/mL received placebo subcutaneous	6	0	6	4	6
EG015	Part D: HBV Participants 75 mg SC	HBV Participants not on NRTI therapy with HBV DNA >/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous	6	0	6	2	6
EG016	Part D: HBV Participants 300 mg SC	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous	6	0	6	6	6
EG017	Part D: HBV Participants Placebo	HBV Participants not on NRTI Therapy with HBV DNA >/= 1000 IU/mL and any HBsAg level received placebo subcutaneous	4	0	4	1	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaphylactic Reaction	Immune system disorders		Systematic Assessment		EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG0030 affected6 at risk EG0040 affected6 at risk EG0050 affected11 at risk EG0060 affected6 at risk EG0070 affected6 at risk EG0080 affected6 at risk EG0090 affected6 at risk EG0100 affected8 at risk EG0110 affected6 at risk EG0120 affected6 at risk EG0131 affected6 at risk EG0140 affected6 at risk EG0150 affected6 at risk EG0160 affected6 at risk EG0170 affected4 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Systematic Assessment	EG0002 affected6 at risk EG0013 affected6 at risk EG0021 affected6 at risk EG0031 affected6 at risk EG0041 affected6 at risk EG0052 affected11 at risk EG0060 affected6 at risk EG0070 affected6 at risk EG0081 affected6 at risk EG0092 affected6 at risk EG0102 affected8 at risk EG0110 affected6 at risk EG0120 affected6 at risk EG0134 affected6 at risk EG0140 affected6 at risk EG0151 affected6 at risk EG0163 affected6 at risk EG0171 affected4 at risk
Injection site erythema	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0013 affected6 at risk EG0021 affected6 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Injection Site Pain	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Chills	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Leukopenia	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Neutropenia	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006521	Hepatitis, Chronic
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Title	Measurements
	BG00031.3± 11.94 BG00127.7± 7.92 BG00231.5± 9.77 BG00324.8± 4.58 BG00429.3± 12.99 BG00530.3± 10.77 BG00656.3± 5.72 BG00749.0± 6.93 BG00850.8± 8.35 BG00950.0± 8.81 BG01051.6± 6.35 BG01144.5± 10.82 BG01238.2± 8.33 BG01338.8± 8.95 BG01444.0± 8.53 BG01542.7± 7.71 BG01638.0± 6.16 BG01737.3± 8.54 BG01839.6± 12.37

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG0022 BG0031 BG0040 BG0051 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG0130 BG0140 BG0150 BG0160 BG0170 BG0184
Not Hispanic or Latino	BG0005 BG0016 BG0024 BG0035 BG004
Unknown or Not Reported	BG0001 BG0010 BG0020 BG0030 BG004

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG0130 BG0140 BG0150 BG0160 BG0170 BG0180
Asian	BG0001 BG0011 BG0020 BG0030 BG004
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0031 BG004
Black or African American	BG0000 BG0010 BG0020 BG0030 BG004
White	BG0003 BG0013 BG0023 BG0034 BG004
More than one race	BG0000 BG0010 BG0020 BG0030 BG004
Unknown or Not Reported	BG0002 BG0012 BG0023 BG0031 BG004

Title	Measurements
	BG0061.94± 0.617 BG0072.78± 0.711 BG0082.55± 0.693 BG0092.59± 1.150 BG0102.24± 0.638 BG0113.34± 0.455 BG0124.12± 0.353 BG0133.71± 0.375 BG0143.18± 1.652 BG0153.79± 0.729 BG0164.29± 0.305 BG0174.15± 0.496 BG0183.17± 1.05

Title

Denominators

Categories

ALT Grade 1

Title	Measurements
	OG0000 OG0011 OG0021 OG0030 OG0042 OG0050 OG0060 OG0070 OG0081 OG0090 OG0100 OG0110 OG0121 OG0130 OG0140 OG0150 OG0165 OG0170

ALT Grade 2

Title	Measurements
	OG0000 OG0010 OG0020 OG003

ALT Grade 3

Title	Measurements
	OG0000 OG0010 OG0020 OG003

ALT Grade 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Alkaline phosphatase Grade 1

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Alkaline phosphatase Grade 2

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Alkaline phosphatase Grade 3

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Alkaline phosphatase Grade 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

AST Grade 1

Title	Measurements
	OG0000 OG0010 OG0021 OG003

AST Grade 2

Title	Measurements
	OG0000 OG0010 OG0021 OG003

AST Grade 3

Title	Measurements
	OG0000 OG0010 OG0020 OG003

AST Grade 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Bilirubin Grade 1

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Bilirubin Grade 2

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Bilirubin Grade 3

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Bilirubin Grade 4

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Title	Measurements
	OG000352± 27.0 OG001456± 152.8 OG0025460± 36.5 OG00319700± 56.9 OG004835± NAIn the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case. OG0054750± 46.9 OG00626100± 21.8 OG0076000± 16.8 OG00810800± 61.4

Title

Denominators

Categories

Title	Measurements
	OG0007.00(3.00 to 7.01) OG0017(3 to 7.00) OG0023(3.00 to 7.00) OG003.0833(0.0417 to 0.292) OG004.0833(0.0417 to 0.0847) OG0056.90(1.01 to 7.00) OG0062.92(1.00 to 6.88) OG0075.44(2.83 to 7.03) OG0082.96(2.11 to 6.97) OG0093.98(3.98 to 3.98) OG0103.00(2.95 to 3.94) OG0112.99(2.86 to 6.97) OG0124.08(0.0417 to 8.11) OG0132.99(2.91 to 3.15)

Title

Denominators

Categories

Title

Measurements

OG0003130± 67.5
OG0014150± 270.0
OG002106000± 72.3
OG003381000± 94.2
OG0049540± NAIn the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case.
OG00539000± 133.0
OG006181,000± 964.4
OG0079,270± 1,139.9
OG00854,300± 122.7

Title

Denominators

Categories

Title	Measurements
	OG00028.5(27.0 to 30.3) OG00124.3(23.2 to 26.6) OG00225.2(21.6 to 28.7) OG00324.0(20.7 to 25.7) OG00420.7(19.3 to 22.7) OG0053.57(2.33 to 4.81) OG0066.34(6.34 to 6.34) OG0077.94(3.54 to 17.2) OG00813.6(5.96 to 16.0) OG0093.82(3.82 to 3.82) OG0104.25(2.48 to 6.02) OG0118.36(4.16 to 11.8) OG0123.17(3.17 to 3.17) OG0131.99(1.99 to 1.99)

Title

Denominators

Categories

Title

Measurements

OG00012200± 15.2
OG00110900± 27.3
OG00210600± 27.7
OG0039420± 12.9
OG0044540± NAthe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG0057410± 21.5
OG0069830± 54.2
OG00710300± NAthe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG0086710± 27.4
OG0097330± 22.5
OG0105000± NAthe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG0114880± NAthe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.

Title

Denominators

Categories

Title

Measurements

OG000295± 16.0
OG001308± 22.7
OG002292± 19.7
OG0031950± 71.2
OG004496± NAThe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG005697± 71.6
OG006653± 85.6
OG0071860± NAThe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG0081200± 111.2
OG009670± 32.8
OG0101090± NAThe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
OG0111700± NAThe SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.

Title

Denominators

Categories

Nadir

Title	Measurements
	OG000-1.30± 0.152 OG001-1.27± 0.666 OG002-1.96± 0.436 OG003-2.24± 0.353 OG004-0.04± 0.039 OG005-1.05± 0.598 OG006-1.28± 0.749 OG007-2.17± 0.252 OG008-0.06± 0.092 OG009-1.77± 0.931 OG010-1.83± 0.219 OG011-0.09± 0.039

Week 4

Title	Measurements
	OG000-0.61± 0.400 OG001-0.38± 0.503 OG002-1.51± 0.245 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0) OG00120(20 to 40) OG002160(160 to 160) OG0030(0 to 0) OG0040(0 to 0) OG0050(0 to 0) OG00640(40 to 40) OG00780(40 to 160) OG008240(20 to 1280) OG009120(80 to 160) OG01080(80 to 80) OG01120(19 to 40) OG01240(20 to 2560) OG01320(20 to 320)

ID	Term
D019694	Hepatitis B, Chronic
D006509	Hepatitis B
D006505	Hepatitis