Trial Outcomes & Findings for A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants (NCT NCT05291520)

Last Updated: 2024-09-19

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	7
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Total n=24 Participants Total of all reporting groups
Age, Continuous	42.8 Years STANDARD_DEVIATION 7.76 • n=99 Participants	40.0 Years STANDARD_DEVIATION 14.45 • n=107 Participants	39.9 Years STANDARD_DEVIATION 10.59 • n=206 Participants	40.87 Years STANDARD_DEVIATION 10.85 • n=7 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	7 Participants n=107 Participants	3 Participants n=206 Participants	15 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants	9 Participants n=7 Participants
Race/Ethnicity, Customized Asian	2 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	4 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants	7 Participants n=7 Participants
Race/Ethnicity, Customized White	5 Participants n=99 Participants	4 Participants n=107 Participants	3 Participants n=206 Participants	12 Participants n=7 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)	8 Participants	—	7 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days post-dose

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)	8 Participants	—	7 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) ALT, Grade 2	0 Participants	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) ALT, Grade 3	0 Participants	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) ALT, Grade 4	0 Participants	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) AST, Grade 2	0 Participants	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) AST, Grade 3	0 Participants	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3) AST, Grade 4	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)	—	—	0 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)	—	—	0 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) ALT, Grade 3	—	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) ALT, Grade 2	—	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) ALT, Grade 4	—	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) AST, Grade 2	—	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) AST, Grade 3	—	—	0 Participants
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) AST, Grade 4	—	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109	31560 Daymicrogram/mililitre (dayμg/mL) Interval 27620.0 to 35490.0	12840 Daymicrogram/mililitre (dayμg/mL) Interval 8883.0 to 16800.0	7587 Daymicrogram/mililitre (dayμg/mL) Interval 4789.0 to 10380.0

SECONDARY outcome

Timeframe: Up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
AUC From Time Zero to Time t (AUC[0-t]) of VH3810109	29160 day*μg/mL Interval 25550.0 to 32770.0	11590 day*μg/mL Interval 7819.0 to 15360.0	6996 day*μg/mL Interval 4512.0 to 9479.0

SECONDARY outcome

Timeframe: Up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Maximum Observed Concentration (Cmax) of VH3810109	1864 μg/mL Interval 1620.0 to 2107.0	321.1 μg/mL Interval 201.6 to 440.6	148.2 μg/mL Interval 117.3 to 179.1

SECONDARY outcome

Timeframe: Up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Time of Maximum Observed Concentration (Tmax) of VH3810109	0.046 Days Interval 0.045 to 0.047	2.882 Days Interval 2.586 to 3.178	4.503 Days Interval 1.472 to 7.535

SECONDARY outcome

Timeframe: Up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Apparent Terminal Phase Half-life (t1/2) of VH3810109	46.97 Days Interval 40.86 to 53.09	44.95 Days Interval 34.14 to 55.76	38.17 Days Interval 23.41 to 52.93

SECONDARY outcome

Timeframe: At Day 2 and Day 7

Population: Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Acceptance of ISRs, Day 2	1.44 Scores on a scale Standard Deviation 0.496	—	1.44 Scores on a scale Standard Deviation 1.050
Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Acceptance of ISRs, Day 7	1.50 Scores on a scale Standard Deviation 0.802	—	1.44 Scores on a scale Standard Deviation 0.729

SECONDARY outcome

Timeframe: At Day 2 and Day 7

Population: Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; the scores are defined as following: 1=not at all bothered, 2=a little bothered, 3=moderately bothered, 4=very bothered, 5=extremely bothered; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Not at all bothered by pain, Day 2	6 Participants	—	6 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) A little bothered by pain, Day 2	2 Participants	—	2 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Moderately bothered by pain, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Very bothered by pain, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Extremely bothered by pain, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Not at all bothered by pain, Day 7	5 Participants	—	5 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) A little bothered by pain, Day 7	3 Participants	—	3 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Moderately bothered by pain, Day 7	0 Participants	—	0 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Very bothered by pain, Day 7	0 Participants	—	0 Participants
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Extremely bothered by pain, Day 7	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: At Day 2 and Day 7

Population: Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; the scores are defind as following: 1=totaly acceptable, 2=very acceptable, 3=moderately acceptable, 4=a little acceptable, 5=not at all acceptable; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Totally acceptable local reactions, Day 2	6 Participants	—	7 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Very acceptable local reactions, Day 2	1 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Moderately acceptable local reactions, Day 2	1 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) A little acceptable local reactions, Day 2	0 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Not at all acceptable local reactions, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Totally acceptable local reactions, Day 7	6 Participants	—	5 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Very acceptable local reactions, Day 7	1 Participants	—	2 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Moderately acceptable local reactions, Day 7	1 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) A little acceptable local reactions, Day 7	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Not at all acceptable local reactions, Day 7	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Totally acceptable pain, Day 2	4 Participants	—	6 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Very acceptable pain, Day 2	4 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Moderately acceptable pain, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) A little acceptable pain, Day 2	0 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Not at all acceptable pain, Day 2	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Totally acceptable pain, Day 7	5 Participants	—	6 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Very acceptable pain, Day 7	1 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Moderately acceptable pain, Day 7	2 Participants	—	1 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) A little acceptable pain, Day 7	0 Participants	—	0 Participants
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3) Not at all acceptable pain, Day 7	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 2 and Day 7

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 1	2.75 Scores on a scale Standard Deviation 2.550	—	3.63 Scores on a scale Standard Deviation 2.326
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 2	0.63 Scores on a scale Standard Deviation 0.744	—	3.63 Scores on a scale Standard Deviation 2.615
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 7	0.38 Scores on a scale Standard Deviation 0.744	—	3.63 Scores on a scale Standard Deviation 2.925

SECONDARY outcome

Timeframe: At Day 1, Day 2 and Day 7

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2) Day 1	—	—	0.50 Scores on a scale Standard Deviation 1.069
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2) Day 2	—	—	0.88 Scores on a scale Standard Deviation 1.642
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2) Day 7	—	—	0.50 Scores on a scale Standard Deviation 1.414

SECONDARY outcome

Timeframe: Up to day 14

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs were recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity was categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated, Grade 5 (death). Higher grade indicates more severe condition.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=18 Number of events Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=14 Number of events Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 2 ISRs	2 Number of events	—	5 Number of events
Number of ISRs Events Overall and by Grade (Part 1 and 3) Overall ISRs	18 Number of events	—	14 Number of events
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 1 ISRs	6 Number of events	—	2 Number of events
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 3 ISRs	10 Number of events	—	7 Number of events
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 4 ISRs	0 Number of events	—	0 Number of events
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 5 ISRs	0 Number of events	—	0 Number of events

SECONDARY outcome

Timeframe: From Day 1 up to Day 14

Population: Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.

ISRs will be recorded via ISR diaries and managed through investigator assessment.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
The Overall Duration of ISRs, Expressed in Days	4.6 Days Standard Deviation 6.29	—	2.9 Days Standard Deviation 1.35

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Population: Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assesseed timepoints and analysis.

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Baseline	0.035 10^9 cells/L Standard Deviation 0.0207	0.044 10^9 cells/L Standard Deviation 0.0106	0.033 10^9 cells/L Standard Deviation 0.0139
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 2	0.000 10^9 cells/L Standard Deviation 0.0151	-0.009 10^9 cells/L Standard Deviation 0.0083	-0.004 10^9 cells/L Standard Deviation 0.0092
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 3	0.005 10^9 cells/L Standard Deviation 0.0152	-0.009 10^9 cells/L Standard Deviation 0.0113	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 4	0.012 10^9 cells/L Standard Deviation 0.0172	-0.001 10^9 cells/L Standard Deviation 0.0181	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 7	0.003 10^9 cells/L Standard Deviation 0.0128	-0.005 10^9 cells/L Standard Deviation 0.0107	0.008 10^9 cells/L Standard Deviation 0.0128
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 8	0.002 10^9 cells/L Standard Deviation 0.0098	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 10	0.000 10^9 cells/L Standard Deviation 0.0283	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 14	0.008 10^9 cells/L Standard Deviation 0.0139	0.003 10^9 cells/L Standard Deviation 0.0149	0.001 10^9 cells/L Standard Deviation 0.0064
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 2	0.010 10^9 cells/L Standard Deviation 0.0151	0.016 10^9 cells/L Standard Deviation 0.0385	0.018 10^9 cells/L Standard Deviation 0.0851
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 4	0.001 10^9 cells/L Standard Deviation 0.0290	-0.004 10^9 cells/L Standard Deviation 0.0403	0.045 10^9 cells/L Standard Deviation 0.0644
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 7	-0.04 10^9 cells/L Standard Deviation 1.171	-0.25 10^9 cells/L Standard Deviation 2.165	0.11 10^9 cells/L Standard Deviation 0.872
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 8	-0.05 10^9 cells/L Standard Deviation 0.997	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 10	-0.85 10^9 cells/L Standard Deviation 0.071	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 14	-0.38 10^9 cells/L Standard Deviation 0.791	-0.25 10^9 cells/L Standard Deviation 0.994	-0.26 10^9 cells/L Standard Deviation 0.809
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 4	-0.40 10^9 cells/L Standard Deviation 0.857	-0.48 10^9 cells/L Standard Deviation 1.340	-0.03 10^9 cells/L Standard Deviation 1.261
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 2	-0.484 10^9 cells/L Standard Deviation 0.3503	-0.094 10^9 cells/L Standard Deviation 0.2147	0.006 10^9 cells/L Standard Deviation 0.1908
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 3	-0.175 10^9 cells/L Standard Deviation 0.3459	-0.135 10^9 cells/L Standard Deviation 0.2727	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 4	-0.065 10^9 cells/L Standard Deviation 0.3551	-0.106 10^9 cells/L Standard Deviation 0.3847	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 7	-0.211 10^9 cells/L Standard Deviation 0.3189	-0.175 10^9 cells/L Standard Deviation 0.3166	-0.043 10^9 cells/L Standard Deviation 0.1763
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Baseline	3.499 10^9 cells/L Standard Deviation 0.9783	3.756 10^9 cells/L Standard Deviation 1.6757	3.218 10^9 cells/L Standard Deviation 0.9157
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 2	0.214 10^9 cells/L Standard Deviation 1.0869	-0.263 10^9 cells/L Standard Deviation 0.9093	0.315 10^9 cells/L Standard Deviation 0.8333
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 7	0.210 10^9 cells/L Standard Deviation 0.9063	-0.079 10^9 cells/L Standard Deviation 1.8480	0.066 10^9 cells/L Standard Deviation 0.8177
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 8	0.160 10^9 cells/L Standard Deviation 0.8802	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 16	-0.468 10^9 cells/L Standard Deviation 0.9437	-0.500 10^9 cells/L Standard Deviation 0.9401	-0.178 10^9 cells/L Standard Deviation 0.6481
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 24	0.691 10^9 cells/L Standard Deviation 2.3541	-0.160 10^9 cells/L Standard Deviation 0.6340	-0.535 10^9 cells/L Standard Deviation 0.8511
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 3	3.2 10^9 cells/L Standard Deviation 19.77	0.1 10^9 cells/L Standard Deviation 19.63	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 4	-4.2 10^9 cells/L Standard Deviation 17.22	-4.9 10^9 cells/L Standard Deviation 20.16	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 4	0.004 10^9 cells/L Standard Deviation 0.0141	0.000 10^9 cells/L Standard Deviation 0.0185	0.003 10^9 cells/L Standard Deviation 0.0139
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 16	0.004 10^9 cells/L Standard Deviation 0.0192	-0.001 10^9 cells/L Standard Deviation 0.0121	-0.001 10^9 cells/L Standard Deviation 0.0083
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 24	0.001 10^9 cells/L Standard Deviation 0.0259	-0.013 10^9 cells/L Standard Deviation 0.0160	0.000 10^9 cells/L Standard Deviation 0.0151
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Baseline	0.098 10^9 cells/L Standard Deviation 0.0333	0.145 10^9 cells/L Standard Deviation 0.1370	0.121 10^9 cells/L Standard Deviation 0.0957
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 3	0.017 10^9 cells/L Standard Deviation 0.0121	0.010 10^9 cells/L Standard Deviation 0.0513	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 4	0.022 10^9 cells/L Standard Deviation 0.0194	0.010 10^9 cells/L Standard Deviation 0.0431	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 7	0.000 10^9 cells/L Standard Deviation 0.0293	0.016 10^9 cells/L Standard Deviation 0.0619	0.016 10^9 cells/L Standard Deviation 0.0964
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 8	0.003 10^9 cells/L Standard Deviation 0.0320	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 10	-0.010 10^9 cells/L Standard Deviation 0.0424	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 14	0.011 10^9 cells/L Standard Deviation 0.0624	0.025 10^9 cells/L Standard Deviation 0.0444	0.059 10^9 cells/L Standard Deviation 0.0718
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 16	0.053 10^9 cells/L Standard Deviation 0.1269	0.013 10^9 cells/L Standard Deviation 0.0605	0.059 10^9 cells/L Standard Deviation 0.1667
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 24	0.094 10^9 cells/L Standard Deviation 0.1445	-0.001 10^9 cells/L Standard Deviation 0.0527	0.001 10^9 cells/L Standard Deviation 0.1063
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Baseline	6.31 10^9 cells/L Standard Deviation 1.365	6.50 10^9 cells/L Standard Deviation 2.036	5.13 10^9 cells/L Standard Deviation 1.161
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 2	-0.31 10^9 cells/L Standard Deviation 1.253	-0.36 10^9 cells/L Standard Deviation 0.980	0.43 10^9 cells/L Standard Deviation 0.696
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 3	0.13 10^9 cells/L Standard Deviation 1.113	-0.41 10^9 cells/L Standard Deviation 1.089	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 4	0.32 10^9 cells/L Standard Deviation 1.386	-0.49 10^9 cells/L Standard Deviation 1.360	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 16	-0.63 10^9 cells/L Standard Deviation 1.073	-0.64 10^9 cells/L Standard Deviation 1.162	0.01 10^9 cells/L Standard Deviation 0.892
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 24	0.40 10^9 cells/L Standard Deviation 2.438	-0.51 10^9 cells/L Standard Deviation 0.540	-0.46 10^9 cells/L Standard Deviation 0.883
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Baseline	2.214 10^9 cells/L Standard Deviation 0.5545	2.086 10^9 cells/L Standard Deviation 0.4824	1.368 10^9 cells/L Standard Deviation 0.2680
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 8	-0.193 10^9 cells/L Standard Deviation 0.3462	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 10	-0.475 10^9 cells/L Standard Deviation 0.0778	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 14	-0.386 10^9 cells/L Standard Deviation 0.3366	-0.161 10^9 cells/L Standard Deviation 0.3561	-0.019 10^9 cells/L Standard Deviation 0.1664
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 4	-0.314 10^9 cells/L Standard Deviation 0.2911	-0.226 10^9 cells/L Standard Deviation 0.2908	0.063 10^9 cells/L Standard Deviation 0.1943
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 16	-0.190 10^9 cells/L Standard Deviation 0.2478	-0.191 10^9 cells/L Standard Deviation 0.3559	0.100 10^9 cells/L Standard Deviation 0.2441
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 24	-0.380 10^9 cells/L Standard Deviation 0.3497	-0.339 10^9 cells/L Standard Deviation 0.4461	0.058 10^9 cells/L Standard Deviation 0.3377
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Baseline	0.461 10^9 cells/L Standard Deviation 0.1038	0.485 10^9 cells/L Standard Deviation 0.1488	0.396 10^9 cells/L Standard Deviation 0.1556
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 2	-0.048 10^9 cells/L Standard Deviation 0.1159	-0.008 10^9 cells/L Standard Deviation 0.0587	0.091 10^9 cells/L Standard Deviation 0.1037
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 3	0.040 10^9 cells/L Standard Deviation 0.0639	-0.013 10^9 cells/L Standard Deviation 0.0886	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 4	0.080 10^9 cells/L Standard Deviation 0.0957	-0.006 10^9 cells/L Standard Deviation 0.1034	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 7	-0.021 10^9 cells/L Standard Deviation 0.1572	-0.013 10^9 cells/L Standard Deviation 0.1413	0.049 10^9 cells/L Standard Deviation 0.1185
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 8	0.008 10^9 cells/L Standard Deviation 0.1019	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 10	-0.110 10^9 cells/L Standard Deviation 0.1131	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 14	-0.078 10^9 cells/L Standard Deviation 0.1237	-0.015 10^9 cells/L Standard Deviation 0.1319	0.034 10^9 cells/L Standard Deviation 0.1347
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 4	-0.045 10^9 cells/L Standard Deviation 0.1146	-0.034 10^9 cells/L Standard Deviation 0.1010	0.036 10^9 cells/L Standard Deviation 0.1061
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 16	-0.029 10^9 cells/L Standard Deviation 0.1221	0.001 10^9 cells/L Standard Deviation 0.0724	0.023 10^9 cells/L Standard Deviation 0.0630
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 24	0.001 10^9 cells/L Standard Deviation 0.1670	-0.020 10^9 cells/L Standard Deviation 0.0462	-0.018 10^9 cells/L Standard Deviation 0.1099
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 3	0.238 10^9 cells/L Standard Deviation 0.9621	-0.291 10^9 cells/L Standard Deviation 0.9503	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 4	0.262 10^9 cells/L Standard Deviation 1.0730	-0.398 10^9 cells/L Standard Deviation 1.0114	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 10	-0.270 10^9 cells/L Standard Deviation 0.3111	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 14	0.096 10^9 cells/L Standard Deviation 0.8912	-0.116 10^9 cells/L Standard Deviation 0.7571	-0.340 10^9 cells/L Standard Deviation 0.7531
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 4	-0.036 10^9 cells/L Standard Deviation 0.9269	-0.233 10^9 cells/L Standard Deviation 1.1531	-0.160 10^9 cells/L Standard Deviation 1.2887
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Baseline	301.9 10^9 cells/L Standard Deviation 34.84	289.5 10^9 cells/L Standard Deviation 71.95	256.3 10^9 cells/L Standard Deviation 48.96
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 2	-14.6 10^9 cells/L Standard Deviation 12.95	1.0 10^9 cells/L Standard Deviation 18.48	6.6 10^9 cells/L Standard Deviation 12.70
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 7	0.0 10^9 cells/L Standard Deviation 13.49	1.9 10^9 cells/L Standard Deviation 23.46	1.4 10^9 cells/L Standard Deviation 13.65
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 8	2.8 10^9 cells/L Standard Deviation 12.14	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 10	-8.0 10^9 cells/L Standard Deviation 19.80	—	—
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 14	1.0 10^9 cells/L Standard Deviation 52.60	2.1 10^9 cells/L Standard Deviation 40.86	19.9 10^9 cells/L Standard Deviation 32.89
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 4	-3.5 10^9 cells/L Standard Deviation 15.10	3.1 10^9 cells/L Standard Deviation 31.31	30.6 10^9 cells/L Standard Deviation 87.1
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 16	6.6 10^9 cells/L Standard Deviation 35.49	-6.4 10^9 cells/L Standard Deviation 31.43	-0.5 10^9 cells/L Standard Deviation 19.34
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 24	12.5 10^9 cells/L Standard Deviation 37.14	-2.3 10^9 cells/L Standard Deviation 27.79	1.1 10^9 cells/L Standard Deviation 27.58

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Hematocrit Baseline	0.3928 Proportion of red blood cells in blood Standard Deviation 0.04415	0.4253 Proportion of red blood cells in blood Standard Deviation 0.04709	0.3873 Proportion of red blood cells in blood Standard Deviation 0.04541
Change From Baseline in Hematocrit Day 2	0.0005 Proportion of red blood cells in blood Standard Deviation 0.01513	0.0118 Proportion of red blood cells in blood Standard Deviation 0.01704	0.0159 Proportion of red blood cells in blood Standard Deviation 0.02226
Change From Baseline in Hematocrit Day 3	0.0100 Proportion of red blood cells in blood Standard Deviation 0.02612	0.0066 Proportion of red blood cells in blood Standard Deviation 0.01502	—
Change From Baseline in Hematocrit Day 4	0.0003 Proportion of red blood cells in blood Standard Deviation 0.01992	0.0023 Proportion of red blood cells in blood Standard Deviation 0.01646	—
Change From Baseline in Hematocrit Day 7	0.0043 Proportion of red blood cells in blood Standard Deviation 0.01521	-0.0065 Proportion of red blood cells in blood Standard Deviation 0.01208	0.0168 Proportion of red blood cells in blood Standard Deviation 0.01662
Change From Baseline in Hematocrit Day 8	0.0062 Proportion of red blood cells in blood Standard Deviation 0.01781	—	—
Change From Baseline in Hematocrit Day 10	-0.0270 Proportion of red blood cells in blood Standard Deviation 0.01131	—	—
Change From Baseline in Hematocrit Day 14	-0.0074 Proportion of red blood cells in blood Standard Deviation 0.01736	-0.0056 Proportion of red blood cells in blood Standard Deviation 0.01420	0.0118 Proportion of red blood cells in blood Standard Deviation 0.01426
Change From Baseline in Hematocrit Week 4	-0.0013 Proportion of red blood cells in blood Standard Deviation 0.01641	-0.0069 Proportion of red blood cells in blood Standard Deviation 0.01605	0.0016 Proportion of red blood cells in blood Standard Deviation 0.01672
Change From Baseline in Hematocrit Week 16	0.0078 Proportion of red blood cells in blood Standard Deviation 0.02315	-0.0106 Proportion of red blood cells in blood Standard Deviation 0.00759	0.0196 Proportion of red blood cells in blood Standard Deviation 0.02303
Change From Baseline in Hematocrit Week 24	0.0053 Proportion of red blood cells in blood Standard Deviation 0.02437	-0.0076 Proportion of red blood cells in blood Standard Deviation 0.03243	0.0119 Proportion of red blood cells in blood Standard Deviation 0.01389

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Red Blood Cell Count (RBC) Week 16	0.124 Trillion cells/L (TI/L) Standard Deviation 0.2212	-0.164 Trillion cells/L (TI/L) Standard Deviation 0.0752	0.186 Trillion cells/L (TI/L) Standard Deviation 0.2612
Change From Baseline in Red Blood Cell Count (RBC) Week 24	0.078 Trillion cells/L (TI/L) Standard Deviation 0.2326	-0.110 Trillion cells/L (TI/L) Standard Deviation 0.3089	0.063 Trillion cells/L (TI/L) Standard Deviation 0.1496
Change From Baseline in Red Blood Cell Count (RBC) Baseline	4.523 Trillion cells/L (TI/L) Standard Deviation 0.4014	4.889 Trillion cells/L (TI/L) Standard Deviation 0.6362	4.518 Trillion cells/L (TI/L) Standard Deviation 0.5518
Change From Baseline in Red Blood Cell Count (RBC) Day 2	0.043 Trillion cells/L (TI/L) Standard Deviation 0.1717	0.141 Trillion cells/L (TI/L) Standard Deviation 0.2154	0.180 Trillion cells/L (TI/L) Standard Deviation 0.2654
Change From Baseline in Red Blood Cell Count (RBC) Day 3	0.163 Trillion cells/L (TI/L) Standard Deviation 0.3064	0.079 Trillion cells/L (TI/L) Standard Deviation 0.1890	—
Change From Baseline in Red Blood Cell Count (RBC) Day 4	0.085 Trillion cells/L (TI/L) Standard Deviation 0.2239	0.056 Trillion cells/L (TI/L) Standard Deviation 0.2169	—
Change From Baseline in Red Blood Cell Count (RBC) Day 7	0.084 Trillion cells/L (TI/L) Standard Deviation 0.1584	-0.074 Trillion cells/L (TI/L) Standard Deviation 0.1429	0.155 Trillion cells/L (TI/L) Standard Deviation 0.2067
Change From Baseline in Red Blood Cell Count (RBC) Day 8	0.088 Trillion cells/L (TI/L) Standard Deviation 0.1877	—	—
Change From Baseline in Red Blood Cell Count (RBC) Day 10	-0.315 Trillion cells/L (TI/L) Standard Deviation 0.1626	—	—
Change From Baseline in Red Blood Cell Count (RBC) Day 14	-0.088 Trillion cells/L (TI/L) Standard Deviation 0.1940	-0.064 Trillion cells/L (TI/L) Standard Deviation 0.1686	0.130 Trillion cells/L (TI/L) Standard Deviation 0.1646
Change From Baseline in Red Blood Cell Count (RBC) Week 4	-0.026 Trillion cells/L (TI/L) Standard Deviation 0.1625	-0.078 Trillion cells/L (TI/L) Standard Deviation 0.1814	0.050 Trillion cells/L (TI/L) Standard Deviation 0.1802

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Mean Corpuscle Volume (MCV) Day 3	-0.72 cubic microns Standard Deviation 0.492	-0.03 cubic microns Standard Deviation 0.345	—
Change From Baseline in Mean Corpuscle Volume (MCV) Day 4	-1.38 cubic microns Standard Deviation 0.542	-0.41 cubic microns Standard Deviation 0.589	—
Change From Baseline in Mean Corpuscle Volume (MCV) Baseline	86.89 cubic microns Standard Deviation 6.081	87.28 cubic microns Standard Deviation 3.478	85.78 cubic microns Standard Deviation 2.013
Change From Baseline in Mean Corpuscle Volume (MCV) Day 2	-0.66 cubic microns Standard Deviation 0.478	-0.03 cubic microns Standard Deviation 0.354	0.14 cubic microns Standard Deviation 0.466
Change From Baseline in Mean Corpuscle Volume (MCV) Day 7	-0.61 cubic microns Standard Deviation 0.562	-0.10 cubic microns Standard Deviation 0.469	0.84 cubic microns Standard Deviation 0.661
Change From Baseline in Mean Corpuscle Volume (MCV) Day 8	-0.27 cubic microns Standard Deviation 0.674	—	—
Change From Baseline in Mean Corpuscle Volume (MCV) Day 10	0.05 cubic microns Standard Deviation 0.354	—	—
Change From Baseline in Mean Corpuscle Volume (MCV) Day 14	0.04 cubic microns Standard Deviation 0.746	0.06 cubic microns Standard Deviation 0.623	0.06 cubic microns Standard Deviation 0.784
Change From Baseline in Mean Corpuscle Volume (MCV) Week 4	0.34 cubic microns Standard Deviation 1.125	-0.03 cubic microns Standard Deviation 0.703	-0.53 cubic microns Standard Deviation 1.216
Change From Baseline in Mean Corpuscle Volume (MCV) Week 16	-0.75 cubic microns Standard Deviation 2.522	0.74 cubic microns Standard Deviation 1.078	0.76 cubic microns Standard Deviation 0.842
Change From Baseline in Mean Corpuscle Volume (MCV) Week 24	-0.41 cubic microns Standard Deviation 2.107	0.40 cubic microns Standard Deviation 2.195	1.34 cubic microns Standard Deviation 1.983

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 8	0.27 picograms (pg) Standard Deviation 0.480	—	—
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Baseline	28.33 picograms (pg) Standard Deviation 2.213	29.26 picograms (pg) Standard Deviation 1.660	29.05 picograms (pg) Standard Deviation 1.028
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 2	0.21 picograms (pg) Standard Deviation 0.458	-0.08 picograms (pg) Standard Deviation 0.345	0.20 picograms (pg) Standard Deviation 0.553
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 3	0.63 picograms (pg) Standard Deviation 0.836	0.39 picograms (pg) Standard Deviation 0.290	—
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 4	0.67 picograms (pg) Standard Deviation 0.463	0.55 picograms (pg) Standard Deviation 0.678	—
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 7	0.16 picograms (pg) Standard Deviation 0.385	0.29 picograms (pg) Standard Deviation 0.536	-0.36 picograms (pg) Standard Deviation 0.302
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 10	-0.20 picograms (pg) Standard Deviation 0.141	—	—
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 14	0.44 picograms (pg) Standard Deviation 0.524	0.33 picograms (pg) Standard Deviation 0.590	-0.06 picograms (pg) Standard Deviation 0.475
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 4	0.39 picograms (pg) Standard Deviation 0.617	0.16 picograms (pg) Standard Deviation 0.466	-0.09 picograms (pg) Standard Deviation 0.608
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 16	0.39 picograms (pg) Standard Deviation 0.779	0.24 picograms (pg) Standard Deviation 0.737	-0.21 picograms (pg) Standard Deviation 0.613
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 24	0.39 picograms (pg) Standard Deviation 0.716	0.31 picograms (pg) Standard Deviation 1.524	-0.39 picograms (pg) Standard Deviation 1.051

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Outcome measures

SECONDARY outcome

Timeframe: Day 14 compared with baseline (Day -1)

Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Glucose	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Protein	1 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Leukocyte esterase	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

ECG values were collected as assessed by protocol, at the indicated time points.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 7	21.083 Miliseconds Standard Deviation 21.4755	8.500 Miliseconds Standard Deviation 13.6498	7.042 Miliseconds Standard Deviation 20.7972
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Week 24	13.167 Miliseconds Standard Deviation 21.5318	15.952 Miliseconds Standard Deviation 10.9771	15.125 Miliseconds Standard Deviation 21.3348
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Baseline	164.000 Miliseconds Standard Deviation 16.6733	164.875 Miliseconds Standard Deviation 14.2872	161.375 Miliseconds Standard Deviation 20.2762
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 1	—	0.500 Miliseconds Standard Deviation 4.5145	-4.000 Miliseconds Standard Deviation 10.7157
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 2	1.917 Miliseconds Standard Deviation 9.5282	3.500 Miliseconds Standard Deviation 7.6677	-0.208 Miliseconds Standard Deviation 7.5297
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 3	3.000 Miliseconds Standard Deviation 10.6354	3.667 Miliseconds Standard Deviation 10.6845	1.083 Miliseconds Standard Deviation 7.8493
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 4	0.875 Miliseconds Standard Deviation 10.8656	3.000 Miliseconds Standard Deviation 10.0775	4.625 Miliseconds Standard Deviation 8.6179
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 7	6.167 Miliseconds Standard Deviation 10.9516	2.625 Miliseconds Standard Deviation 6.3507	1.458 Miliseconds Standard Deviation 11.6223
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 8	5.875 Miliseconds Standard Deviation 9.4330	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Day 10	19.167 Miliseconds Standard Deviation 8.7210	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Week 4	4.250 Miliseconds Standard Deviation 11.7700	-2.250 Miliseconds Standard Deviation 10.6231	9.542 Miliseconds Standard Deviation 5.9038
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) PR Interval, at Week 24	-0.958 Miliseconds Standard Deviation 11.6571	-1.905 Miliseconds Standard Deviation 12.0872	4.583 Miliseconds Standard Deviation 10.1164
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Baseline	90.750 Miliseconds Standard Deviation 11.8291	100.250 Miliseconds Standard Deviation 12.1155	92.875 Miliseconds Standard Deviation 8.1141
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 1	—	-5.250 Miliseconds Standard Deviation 6.8098	0.875 Miliseconds Standard Deviation 3.5587
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 2	-0.458 Miliseconds Standard Deviation 3.7116	-3.708 Miliseconds Standard Deviation 5.6833	-2.292 Miliseconds Standard Deviation 2.6693
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 3	-2.833 Miliseconds Standard Deviation 6.2463	-2.583 Miliseconds Standard Deviation 3.6764	-0.875 Miliseconds Standard Deviation 2.3363
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 4	-1.875 Miliseconds Standard Deviation 6.0708	-4.458 Miliseconds Standard Deviation 6.4855	1.458 Miliseconds Standard Deviation 5.0895
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 7	-1.500 Miliseconds Standard Deviation 6.8359	-2.917 Miliseconds Standard Deviation 6.3164	0.000 Miliseconds Standard Deviation 5.1052
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 8	-1.042 Miliseconds Standard Deviation 4.6987	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Day 10	-4.333 Miliseconds Standard Deviation 6.5997	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Week 4	-0.958 Miliseconds Standard Deviation 3.8398	-4.708 Miliseconds Standard Deviation 6.2372	0.708 Miliseconds Standard Deviation 3.9337
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QRS Interval, at Week 24	-0.458 Miliseconds Standard Deviation 4.4755	-5.238 Miliseconds Standard Deviation 6.4599	-0.917 Miliseconds Standard Deviation 4.5066
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Baseline	395.875 Miliseconds Standard Deviation 19.1493	380.375 Miliseconds Standard Deviation 12.3513	378.875 Miliseconds Standard Deviation 17.7719
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 1	—	-0.625 Miliseconds Standard Deviation 8.6620	0.708 Miliseconds Standard Deviation 12.1713
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 2	20.750 Miliseconds Standard Deviation 18.9684	16.083 Miliseconds Standard Deviation 13.6449	4.750 Miliseconds Standard Deviation 12.1299
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 3	10.542 Miliseconds Standard Deviation 27.0566	9.792 Miliseconds Standard Deviation 12.7179	8.583 Miliseconds Standard Deviation 18.2650
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 4	7.000 Miliseconds Standard Deviation 27.0725	9.167 Miliseconds Standard Deviation 18.5267	5.917 Miliseconds Standard Deviation 22.1616
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 8	19.167 Miliseconds Standard Deviation 20.0206	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Day 10	31.667 Miliseconds Standard Deviation 55.1543	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QT Interval, at Week 4	31.167 Miliseconds Standard Deviation 17.0023	10.583 Miliseconds Standard Deviation 13.7318	14.083 Miliseconds Standard Deviation 18.0614
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Baseline	419.375 Miliseconds Standard Deviation 13.7523	397.000 Miliseconds Standard Deviation 14.8131	402.750 Miliseconds Standard Deviation 10.5119
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 1	—	1.375 Miliseconds Standard Deviation 9.1780	2.833 Miliseconds Standard Deviation 10.0570
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 2	1.083 Miliseconds Standard Deviation 15.4486	3.375 Miliseconds Standard Deviation 11.7924	-1.875 Miliseconds Standard Deviation 9.2923
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 3	-1.250 Miliseconds Standard Deviation 14.9047	2.083 Miliseconds Standard Deviation 8.6295	0.917 Miliseconds Standard Deviation 9.5232
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 4	-4.292 Miliseconds Standard Deviation 18.3220	1.917 Miliseconds Standard Deviation 9.0847	-2.000 Miliseconds Standard Deviation 15.0449
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 7	0.958 Miliseconds Standard Deviation 9.6715	3.500 Miliseconds Standard Deviation 11.9004	8.667 Miliseconds Standard Deviation 22.8341
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 8	1.833 Miliseconds Standard Deviation 14.8410	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Day 10	0.667 Miliseconds Standard Deviation 33.9411	—	—
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Week 4	6.500 Miliseconds Standard Deviation 8.8515	2.250 Miliseconds Standard Deviation 8.4867	1.167 Miliseconds Standard Deviation 10.6398
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) QTcF Interval, at Week 24	2.229 Miliseconds Standard Deviation 14.8754	7.238 Miliseconds Standard Deviation 5.6461	2.417 Miliseconds Standard Deviation 10.5991

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Temperature Day 2	-0.48 Degrees Celcius Standard Deviation 0.437	-0.14 Degrees Celcius Standard Deviation 0.342	-0.10 Degrees Celcius Standard Deviation 0.424
Change From Baseline in Temperature Day 3	-0.50 Degrees Celcius Standard Deviation 0.475	-0.25 Degrees Celcius Standard Deviation 0.454	-0.23 Degrees Celcius Standard Deviation 0.365
Change From Baseline in Temperature Day 4	-0.41 Degrees Celcius Standard Deviation 0.569	-0.20 Degrees Celcius Standard Deviation 0.463	-0.03 Degrees Celcius Standard Deviation 0.311
Change From Baseline in Temperature Day 7	-0.41 Degrees Celcius Standard Deviation 0.622	-0.04 Degrees Celcius Standard Deviation 0.578	-0.05 Degrees Celcius Standard Deviation 0.524
Change From Baseline in Temperature Day 8	-0.41 Degrees Celcius Standard Deviation 0.599	—	—
Change From Baseline in Temperature Day 10	-0.60 Degrees Celcius Standard Deviation 0.566	—	—
Change From Baseline in Temperature Day 14	-0.28 Degrees Celcius Standard Deviation 0.492	-0.28 Degrees Celcius Standard Deviation 0.453	-0.13 Degrees Celcius Standard Deviation 0.392
Change From Baseline in Temperature Day 21	-0.49 Degrees Celcius Standard Deviation 0.352	-0.04 Degrees Celcius Standard Deviation 0.469	-0.11 Degrees Celcius Standard Deviation 0.554
Change From Baseline in Temperature Week 4	-0.56 Degrees Celcius Standard Deviation 0.534	-0.09 Degrees Celcius Standard Deviation 0.549	-0.21 Degrees Celcius Standard Deviation 0.364
Change From Baseline in Temperature Baseline	36.79 Degrees Celcius Standard Deviation 0.344	36.49 Degrees Celcius Standard Deviation 0.500	36.54 Degrees Celcius Standard Deviation 0.233
Change From Baseline in Temperature Week 8	-0.45 Degrees Celcius Standard Deviation 0.535	-0.20 Degrees Celcius Standard Deviation 0.566	-0.28 Degrees Celcius Standard Deviation 0.399
Change From Baseline in Temperature Week 12	-0.33 Degrees Celcius Standard Deviation 0.607	-0.28 Degrees Celcius Standard Deviation 0.423	-0.23 Degrees Celcius Standard Deviation 0.271
Change From Baseline in Temperature Week 16	-0.33 Degrees Celcius Standard Deviation 0.575	-0.69 Degrees Celcius Standard Deviation 0.534	-0.34 Degrees Celcius Standard Deviation 0.346
Change From Baseline in Temperature Week 20	-0.40 Degrees Celcius Standard Deviation 0.414	-0.19 Degrees Celcius Standard Deviation 0.505	-0.17 Degrees Celcius Standard Deviation 0.315
Change From Baseline in Temperature Week 24	-0.55 Degrees Celcius Standard Deviation 0.678	0.09 Degrees Celcius Standard Deviation 0.367	-0.19 Degrees Celcius Standard Deviation 0.364

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline (Day -1) up to Week 24

Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.

Outcome measures

Adverse Events

Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2 Group: VH3810109 60 mg/kg [IV]

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 4	0.4 Grams per liter (g/L) Standard Deviation 6.55	-1.4 Grams per liter (g/L) Standard Deviation 4.96	1.0 Grams per liter (g/L) Standard Deviation 5.29
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Baseline	43.9 Grams per liter (g/L) Standard Deviation 3.00	43.9 Grams per liter (g/L) Standard Deviation 3.44	44.0 Grams per liter (g/L) Standard Deviation 3.02
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 4	-0.1 Grams per liter (g/L) Standard Deviation 2.10	-0.3 Grams per liter (g/L) Standard Deviation 2.43	-1.4 Grams per liter (g/L) Standard Deviation 2.56
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 24	-0.3 Grams per liter (g/L) Standard Deviation 1.04	-1.9 Grams per liter (g/L) Standard Deviation 2.48	-1.5 Grams per liter (g/L) Standard Deviation 2.14
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Baseline	71.0 Grams per liter (g/L) Standard Deviation 3.66	72.3 Grams per liter (g/L) Standard Deviation 4.40	70.0 Grams per liter (g/L) Standard Deviation 3.85
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 2	-1.4 Grams per liter (g/L) Standard Deviation 4.17	-1.5 Grams per liter (g/L) Standard Deviation 3.51	0.6 Grams per liter (g/L) Standard Deviation 4.17
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 3	6.8 Grams per liter (g/L) Standard Deviation 6.79	4.3 Grams per liter (g/L) Standard Deviation 5.39	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 4	4.8 Grams per liter (g/L) Standard Deviation 7.19	3.9 Grams per liter (g/L) Standard Deviation 5.46	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 7	2.9 Grams per liter (g/L) Standard Deviation 5.28	-0.4 Grams per liter (g/L) Standard Deviation 4.37	2.6 Grams per liter (g/L) Standard Deviation 6.35
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 8	3.3 Grams per liter (g/L) Standard Deviation 4.84	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 10	-10.0 Grams per liter (g/L) Standard Deviation 4.24	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 14	-0.8 Grams per liter (g/L) Standard Deviation 5.90	-0.4 Grams per liter (g/L) Standard Deviation 4.47	3.4 Grams per liter (g/L) Standard Deviation 4.78
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 16	5.3 Grams per liter (g/L) Standard Deviation 8.01	-3.4 Grams per liter (g/L) Standard Deviation 4.12	4.3 Grams per liter (g/L) Standard Deviation 7.23
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 24	4.0 Grams per liter (g/L) Standard Deviation 7.54	-1.4 Grams per liter (g/L) Standard Deviation 13.99	0.4 Grams per liter (g/L) Standard Deviation 4.07
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 2	-2.4 Grams per liter (g/L) Standard Deviation 2.45	-0.3 Grams per liter (g/L) Standard Deviation 1.83	0.4 Grams per liter (g/L) Standard Deviation 2.07
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 3	-0.3 Grams per liter (g/L) Standard Deviation 1.86	-0.1 Grams per liter (g/L) Standard Deviation 1.73	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 4	-0.8 Grams per liter (g/L) Standard Deviation 2.40	0.3 Grams per liter (g/L) Standard Deviation 1.58	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 7	-1.9 Grams per liter (g/L) Standard Deviation 1.81	0.4 Grams per liter (g/L) Standard Deviation 2.00	0.1 Grams per liter (g/L) Standard Deviation 2.80
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 8	-1.7 Grams per liter (g/L) Standard Deviation 1.75	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 10	-5.5 Grams per liter (g/L) Standard Deviation 0.71	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 14	-1.0 Grams per liter (g/L) Standard Deviation 1.51	-0.1 Grams per liter (g/L) Standard Deviation 1.89	0.0 Grams per liter (g/L) Standard Deviation 2.00
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 16	0.8 Grams per liter (g/L) Standard Deviation 2.19	-2.0 Grams per liter (g/L) Standard Deviation 2.16	0.6 Grams per liter (g/L) Standard Deviation 1.77
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 3	1.3 Grams per liter (g/L) Standard Deviation 3.93	-1.9 Grams per liter (g/L) Standard Deviation 3.04	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 4	0.0 Grams per liter (g/L) Standard Deviation 4.43	0.6 Grams per liter (g/L) Standard Deviation 2.20	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 7	-2.8 Grams per liter (g/L) Standard Deviation 2.76	-0.1 Grams per liter (g/L) Standard Deviation 3.52	0.0 Grams per liter (g/L) Standard Deviation 4.57
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 8	2.76 Grams per liter (g/L) Standard Deviation 2.86	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 10	-8.0 Grams per liter (g/L) Standard Deviation 0.00	—	—
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 14	-1.6 Grams per liter (g/L) Standard Deviation 2.56	-0.8 Grams per liter (g/L) Standard Deviation 2.71	0.0 Grams per liter (g/L) Standard Deviation 4.14
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 4	-1.0 Grams per liter (g/L) Standard Deviation 3.38	-1.9 Grams per liter (g/L) Standard Deviation 3.14	-0.6 Grams per liter (g/L) Standard Deviation 3.16
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 16	1.0 Grams per liter (g/L) Standard Deviation 3.85	-4.4 Grams per liter (g/L) Standard Deviation 3.87	0.9 Grams per liter (g/L) Standard Deviation 2.42
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 24	0.1 Grams per liter (g/L) Standard Deviation 2.17	-2.7 Grams per liter (g/L) Standard Deviation 4.46	-3.4 Grams per liter (g/L) Standard Deviation 3.96
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Baseline	128.3 Grams per liter (g/L) Standard Deviation 15.83	142.4 Grams per liter (g/L) Standard Deviation 15.67	131.4 Grams per liter (g/L) Standard Deviation 16.78
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 2	1.9 Grams per liter (g/L) Standard Deviation 4.61	3.9 Grams per liter (g/L) Standard Deviation 6.49	5.8 Grams per liter (g/L) Standard Deviation 6.90

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Week 24	0.26775 milligram per deciliter (mg/dL) Standard Deviation 1.474420	-0.05610 milligram per deciliter (mg/dL) Standard Deviation 1.187055	0.32576 milligram per deciliter (mg/dL) Standard Deviation 1.074638
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 7	2.4310 milligram per deciliter (mg/dL) Standard Deviation 6.71158	6.2985 milligram per deciliter (mg/dL) Standard Deviation 9.30077	0.0000 milligram per deciliter (mg/dL) Standard Deviation 5.84472
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 7	0.0214 milligram per deciliter (mg/dL) Standard Deviation 0.42320	-0.1283 milligram per deciliter (mg/dL) Standard Deviation 0.33893	0.0000 milligram per deciliter (mg/dL) Standard Deviation 0.43836
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 8	0.1995 milligram per deciliter (mg/dL) Standard Deviation 0.53440	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 10	-0.5130 milligram per deciliter (mg/dL) Standard Deviation 0.48366	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 14	-0.3634 milligram per deciliter (mg/dL) Standard Deviation 0.46997	-0.1710 milligram per deciliter (mg/dL) Standard Deviation 0.44778	-0.2351 milligram per deciliter (mg/dL) Standard Deviation 0.57763
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 4	0.0000 milligram per deciliter (mg/dL) Standard Deviation 0.42872	-0.1496 milligram per deciliter (mg/dL) Standard Deviation 0.50427	-0.5344 milligram per deciliter (mg/dL) Standard Deviation 0.62287
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 16	-0.2138 milligram per deciliter (mg/dL) Standard Deviation 0.52308	-0.7817 milligram per deciliter (mg/dL) Standard Deviation 0.56591	-0.3206 milligram per deciliter (mg/dL) Standard Deviation 0.59544
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 24	-0.2565 milligram per deciliter (mg/dL) Standard Deviation 0.61993	-0.3176 milligram per deciliter (mg/dL) Standard Deviation 0.36178	-0.3420 milligram per deciliter (mg/dL) Standard Deviation 0.49222
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Baseline	10.4738 milligram per deciliter (mg/dL) Standard Deviation 3.28512	12.5258 milligram per deciliter (mg/dL) Standard Deviation 7.47987	9.7684 milligram per deciliter (mg/dL) Standard Deviation 3.95623
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 2	-1.1115 milligram per deciliter (mg/dL) Standard Deviation 3.08613	0.6413 milligram per deciliter (mg/dL) Standard Deviation 2.98813	-1.9879 milligram per deciliter (mg/dL) Standard Deviation 2.22382
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 3	-0.8550 milligram per deciliter (mg/dL) Standard Deviation 2.99128	0.4061 milligram per deciliter (mg/dL) Standard Deviation 3.48526	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 4	0.0570 milligram per deciliter (mg/dL) Standard Deviation 2.84018	2.0306 milligram per deciliter (mg/dL) Standard Deviation 4.64850	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 7	-0.2565 milligram per deciliter (mg/dL) Standard Deviation 3.16102	-0.4703 milligram per deciliter (mg/dL) Standard Deviation 2.08181	1.6031 milligram per deciliter (mg/dL) Standard Deviation 2.82603
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 8	0.9405 milligram per deciliter (mg/dL) Standard Deviation 3.54057	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 10	-2.3085 milligram per deciliter (mg/dL) Standard Deviation 1.81373	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 14	-2.4368 milligram per deciliter (mg/dL) Standard Deviation 2.07377	-0.6199 milligram per deciliter (mg/dL) Standard Deviation 3.52222	0.6199 milligram per deciliter (mg/dL) Standard Deviation 3.02728
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 4	-1.1115 milligram per deciliter (mg/dL) Standard Deviation 1.51851	-0.3206 milligram per deciliter (mg/dL) Standard Deviation 3.67145	-1.7528 milligram per deciliter (mg/dL) Standard Deviation 3.77392
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 16	-1.5390 milligram per deciliter (mg/dL) Standard Deviation 2.90772	-2.4917 milligram per deciliter (mg/dL) Standard Deviation 2.46196	-0.4061 milligram per deciliter (mg/dL) Standard Deviation 3.45758
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 24	-0.6840 milligram per deciliter (mg/dL) Standard Deviation 3.10368	-1.6856 milligram per deciliter (mg/dL) Standard Deviation 2.63700	0.0428 milligram per deciliter (mg/dL) Standard Deviation 2.98813
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Baseline	5.037533 milligram per deciliter (mg/dL) Standard Deviation 0.2582430	4.864064 milligram per deciliter (mg/dL) Standard Deviation 0.2032812	5.009778 milligram per deciliter (mg/dL) Standard Deviation 0.2649736
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 2	0.256734 milligram per deciliter (mg/dL) Standard Deviation 0.5881647	0.145714 milligram per deciliter (mg/dL) Standard Deviation 0.2966207	-0.006939 milligram per deciliter (mg/dL) Standard Deviation 0.2306696
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 3	-0.018503 milligram per deciliter (mg/dL) Standard Deviation 0.2930311	0.201224 milligram per deciliter (mg/dL) Standard Deviation 0.3645321	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 4	-0.027755 milligram per deciliter (mg/dL) Standard Deviation 0.2868315	-0.006939 milligram per deciliter (mg/dL) Standard Deviation 0.2852734	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 7	0.548161 milligram per deciliter (mg/dL) Standard Deviation 1.1531574	0.166530 milligram per deciliter (mg/dL) Standard Deviation 0.3408978	0.180408 milligram per deciliter (mg/dL) Standard Deviation 0.1723749
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 8	-0.111020 milligram per deciliter (mg/dL) Standard Deviation 0.3330600	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 10	0.000000 milligram per deciliter (mg/dL) Standard Deviation 0.1570060	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 14	0.048571 milligram per deciliter (mg/dL) Standard Deviation 0.3884992	0.006939 milligram per deciliter (mg/dL) Standard Deviation 0.2790329	-0.027755 milligram per deciliter (mg/dL) Standard Deviation 0.2586688
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 4	-0.124898 milligram per deciliter (mg/dL) Standard Deviation 0.2842106	0.215101 milligram per deciliter (mg/dL) Standard Deviation 0.5168587	0.027755 milligram per deciliter (mg/dL) Standard Deviation 0.3857275
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 16	0.076326 milligram per deciliter (mg/dL) Standard Deviation 0.2138345	0.111020 milligram per deciliter (mg/dL) Standard Deviation 0.3376541	-0.180408 milligram per deciliter (mg/dL) Standard Deviation 0.2254827
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 24	-0.208163 milligram per deciliter (mg/dL) Standard Deviation 0.3557469	0.237900 milligram per deciliter (mg/dL) Standard Deviation 0.3184202	-0.249795 milligram per deciliter (mg/dL) Standard Deviation 0.3040408
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Baseline	4.19475 milligram per deciliter (mg/dL) Standard Deviation 1.376981	4.73025 milligram per deciliter (mg/dL) Standard Deviation 1.594955	3.83775 milligram per deciliter (mg/dL) Standard Deviation 0.731134
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 2	0.39270 milligram per deciliter (mg/dL) Standard Deviation 0.937762	0.27221 milligram per deciliter (mg/dL) Standard Deviation 1.307383	1.21380 milligram per deciliter (mg/dL) Standard Deviation 0.678703
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 3	0.67830 milligram per deciliter (mg/dL) Standard Deviation 0.651268	0.16511 milligram per deciliter (mg/dL) Standard Deviation 1.369415	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 4	0.82705 milligram per deciliter (mg/dL) Standard Deviation 0.927490	0.15619 milligram per deciliter (mg/dL) Standard Deviation 1.726718	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 7	0.58459 milligram per deciliter (mg/dL) Standard Deviation 1.250583	-0.42840 milligram per deciliter (mg/dL) Standard Deviation 1.421995	0.30345 milligram per deciliter (mg/dL) Standard Deviation 1.042747
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 8	0.55930 milligram per deciliter (mg/dL) Standard Deviation 0.809900	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 10	0.35700 milligram per deciliter (mg/dL) Standard Deviation 0.000000	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 14	-0.33915 milligram per deciliter (mg/dL) Standard Deviation 1.192768	-0.50873 milligram per deciliter (mg/dL) Standard Deviation 1.656633	0.02678 milligram per deciliter (mg/dL) Standard Deviation 0.714446
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Week 4	-0.16065 milligram per deciliter (mg/dL) Standard Deviation 0.695659	-0.24098 milligram per deciliter (mg/dL) Standard Deviation 1.082288	0.31684 milligram per deciliter (mg/dL) Standard Deviation 0.895135
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Week 16	-0.41948 milligram per deciliter (mg/dL) Standard Deviation 0.805711	0.03060 milligram per deciliter (mg/dL) Standard Deviation 1.359639	0.21420 milligram per deciliter (mg/dL) Standard Deviation 1.260309
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Baseline	68.0680 milligram per deciliter (mg/dL) Standard Deviation 13.56381	73.8140 milligram per deciliter (mg/dL) Standard Deviation 15.20157	68.2890 milligram per deciliter (mg/dL) Standard Deviation 15.18504
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 2	-3.2045 milligram per deciliter (mg/dL) Standard Deviation 3.97975	2.3205 milligram per deciliter (mg/dL) Standard Deviation 9.02667	1.4365 milligram per deciliter (mg/dL) Standard Deviation 8.05969
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 3	-0.7367 milligram per deciliter (mg/dL) Standard Deviation 6.16058	3.6465 milligram per deciliter (mg/dL) Standard Deviation 5.49905	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 4	-0.5893 milligram per deciliter (mg/dL) Standard Deviation 6.03887	0.8840 milligram per deciliter (mg/dL) Standard Deviation 7.94898	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 8	-0.4420 milligram per deciliter (mg/dL) Standard Deviation 6.01510	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 10	11.9340 milligram per deciliter (mg/dL) Standard Deviation 3.12541	—	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 14	0.6630 milligram per deciliter (mg/dL) Standard Deviation 6.49175	3.4255 milligram per deciliter (mg/dL) Standard Deviation 5.98510	0.1105 milligram per deciliter (mg/dL) Standard Deviation 3.82236
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 4	0.1105 milligram per deciliter (mg/dL) Standard Deviation 4.18485	2.7625 milligram per deciliter (mg/dL) Standard Deviation 6.78911	2.9835 milligram per deciliter (mg/dL) Standard Deviation 7.05521
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 16	-0.7735 milligram per deciliter (mg/dL) Standard Deviation 7.98314	3.1571 milligram per deciliter (mg/dL) Standard Deviation 5.32501	-0.3315 milligram per deciliter (mg/dL) Standard Deviation 6.87895
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 24	-0.2210 milligram per deciliter (mg/dL) Standard Deviation 5.62574	5.6829 milligram per deciliter (mg/dL) Standard Deviation 7.60201	2.0995 milligram per deciliter (mg/dL) Standard Deviation 4.25102
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Baseline	1.7741 milligram per deciliter (mg/dL) Standard Deviation 0.62621	2.1161 milligram per deciliter (mg/dL) Standard Deviation 1.04191	2.0306 milligram per deciliter (mg/dL) Standard Deviation 0.49592
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 2	-0.2138 milligram per deciliter (mg/dL) Standard Deviation 0.45473	-0.0214 milligram per deciliter (mg/dL) Standard Deviation 0.44250	-0.5771 milligram per deciliter (mg/dL) Standard Deviation 0.42811
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 3	-0.1425 milligram per deciliter (mg/dL) Standard Deviation 0.45134	-0.1069 milligram per deciliter (mg/dL) Standard Deviation 0.43776	—
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 4	0.0285 milligram per deciliter (mg/dL) Standard Deviation 0.47656	0.1283 milligram per deciliter (mg/dL) Standard Deviation 0.58348	—

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Week 16	0.018713 Millimole per liter (mmol/L) Standard Deviation 0.0751464	-0.064157 Millimole per liter (mmol/L) Standard Deviation 0.0496021	-0.015594 Millimole per liter (mmol/L) Standard Deviation 0.0842805
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Baseline	102.1 Millimole per liter (mmol/L) Standard Deviation 2.59	102.4 Millimole per liter (mmol/L) Standard Deviation 2.20	103.1 Millimole per liter (mmol/L) Standard Deviation 1.81
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 2	0.0 Millimole per liter (mmol/L) Standard Deviation 2.00	0.1 Millimole per liter (mmol/L) Standard Deviation 2.42	-0.6 Millimole per liter (mmol/L) Standard Deviation 2.45
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 4	-1.5 Millimole per liter (mmol/L) Standard Deviation 1.64	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.39	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 7	0.1 Millimole per liter (mmol/L) Standard Deviation 1.64	0.5 Millimole per liter (mmol/L) Standard Deviation 2.14	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.07
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Week 4	1.1 Millimole per liter (mmol/L) Standard Deviation 2.47	0.4 Millimole per liter (mmol/L) Standard Deviation 1.06	-1.3 Millimole per liter (mmol/L) Standard Deviation 2.38
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Week 24	0.6 Millimole per liter (mmol/L) Standard Deviation 2.26	1.7 Millimole per liter (mmol/L) Standard Deviation 2.21	-0.1 Millimole per liter (mmol/L) Standard Deviation 2.36
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Baseline	4.14 Millimole per liter (mmol/L) Standard Deviation 0.342	4.29 Millimole per liter (mmol/L) Standard Deviation 0.485	4.36 Millimole per liter (mmol/L) Standard Deviation 0.484
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 2	0.16 Millimole per liter (mmol/L) Standard Deviation 0.325	0.10 Millimole per liter (mmol/L) Standard Deviation 0.366	0.09 Millimole per liter (mmol/L) Standard Deviation 0.242
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Baseline	2.317231 Millimole per liter (mmol/L) Standard Deviation 0.0805028	2.351538 Millimole per liter (mmol/L) Standard Deviation 0.0931159	2.329706 Millimole per liter (mmol/L) Standard Deviation 0.1049575
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 2	-0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0983979	-0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0983979	-0.015594 Millimole per liter (mmol/L) Standard Deviation 0.1041067
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 3	0.037425 Millimole per liter (mmol/L) Standard Deviation 0.1101762	0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0759557	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 4	0.008317 Millimole per liter (mmol/L) Standard Deviation 0.1145166	0.040544 Millimole per liter (mmol/L) Standard Deviation 0.0729700	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 7	-0.006238 Millimole per liter (mmol/L) Standard Deviation 0.0830180	0.037425 Millimole per liter (mmol/L) Standard Deviation 0.0442316	-0.012475 Millimole per liter (mmol/L) Standard Deviation 0.0533453
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 8	-0.004158 Millimole per liter (mmol/L) Standard Deviation 0.0639356	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 10	-0.112275 Millimole per liter (mmol/L) Standard Deviation 0.0882116	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 14	-0.034306 Millimole per liter (mmol/L) Standard Deviation 0.0923367	-0.009356 Millimole per liter (mmol/L) Standard Deviation 0.0923367	0.009356 Millimole per liter (mmol/L) Standard Deviation 0.0398698
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Week 4	-0.034306 Millimole per liter (mmol/L) Standard Deviation 0.0853291	0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0826826	-0.031188 Millimole per liter (mmol/L) Standard Deviation 0.0739536
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Week 24	-0.031188 Millimole per liter (mmol/L) Standard Deviation 0.0371268	-0.053464 Millimole per liter (mmol/L) Standard Deviation 0.1002445	-0.056138 Millimole per liter (mmol/L) Standard Deviation 0.0861717
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Baseline	27.8 Millimole per liter (mmol/L) Standard Deviation 2.25	28.6 Millimole per liter (mmol/L) Standard Deviation 1.92	29.4 Millimole per liter (mmol/L) Standard Deviation 1.77
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 2	0.6 Millimole per liter (mmol/L) Standard Deviation 1.19	0.4 Millimole per liter (mmol/L) Standard Deviation 1.41	0.5 Millimole per liter (mmol/L) Standard Deviation 1.41
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 3	1.5 Millimole per liter (mmol/L) Standard Deviation 0.84	-0.5 Millimole per liter (mmol/L) Standard Deviation 0.93	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 4	1.3 Millimole per liter (mmol/L) Standard Deviation 1.03	0.3 Millimole per liter (mmol/L) Standard Deviation 1.28	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 7	0.3 Millimole per liter (mmol/L) Standard Deviation 1.28	0.3 Millimole per liter (mmol/L) Standard Deviation 0.71	-0.3 Millimole per liter (mmol/L) Standard Deviation 1.39
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 8	1.3 Millimole per liter (mmol/L) Standard Deviation 1.03	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 10	0.0 Millimole per liter (mmol/L) Standard Deviation 1.41	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 14	0.5 Millimole per liter (mmol/L) Standard Deviation 1.51	-0.4 Millimole per liter (mmol/L) Standard Deviation 1.41	0.3 Millimole per liter (mmol/L) Standard Deviation 0.89
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 4	0.9 Millimole per liter (mmol/L) Standard Deviation 1.64	0.0 Millimole per liter (mmol/L) Standard Deviation 0.93	1.5 Millimole per liter (mmol/L) Standard Deviation 1.51
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 16	0.3 Millimole per liter (mmol/L) Standard Deviation 0.71	-0.4 Millimole per liter (mmol/L) Standard Deviation 0.98	-1.3 Millimole per liter (mmol/L) Standard Deviation 1.28
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 24	0.4 Millimole per liter (mmol/L) Standard Deviation 1.51	0.3 Millimole per liter (mmol/L) Standard Deviation 1.38	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.20
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 3	-1.2 Millimole per liter (mmol/L) Standard Deviation 1.94	-0.3 Millimole per liter (mmol/L) Standard Deviation 2.49	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 8	0.3 Millimole per liter (mmol/L) Standard Deviation 1.75	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 10	5.5 Millimole per liter (mmol/L) Standard Deviation 2.12	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 14	1.0 Millimole per liter (mmol/L) Standard Deviation 2.56	0.4 Millimole per liter (mmol/L) Standard Deviation 2.13	-1.6 Millimole per liter (mmol/L) Standard Deviation 1.77
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Week 16	1.5 Millimole per liter (mmol/L) Standard Deviation 1.41	0.7 Millimole per liter (mmol/L) Standard Deviation 1.80	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.13
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 3	0.13 Millimole per liter (mmol/L) Standard Deviation 0.372	0.14 Millimole per liter (mmol/L) Standard Deviation 0.250	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 4	0.00 Millimole per liter (mmol/L) Standard Deviation 0.544	0.13 Millimole per liter (mmol/L) Standard Deviation 0.320	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 7	0.29 Millimole per liter (mmol/L) Standard Deviation 0.470	-0.01 Millimole per liter (mmol/L) Standard Deviation 0.340	-0.30 Millimole per liter (mmol/L) Standard Deviation 0.421
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 8	0.07 Millimole per liter (mmol/L) Standard Deviation 0.207	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 10	0.45 Millimole per liter (mmol/L) Standard Deviation 0.354	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 14	0.04 Millimole per liter (mmol/L) Standard Deviation 0.513	0.09 Millimole per liter (mmol/L) Standard Deviation 0.458	-0.13 Millimole per liter (mmol/L) Standard Deviation 0.381
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 4	0.18 Millimole per liter (mmol/L) Standard Deviation 0.183	-0.01 Millimole per liter (mmol/L) Standard Deviation 0.196	-0.16 Millimole per liter (mmol/L) Standard Deviation 0.389
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 16	0.11 Millimole per liter (mmol/L) Standard Deviation 0.189	-0.04 Millimole per liter (mmol/L) Standard Deviation 0.382	-0.38 Millimole per liter (mmol/L) Standard Deviation 0.413
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 24	-0.03 Millimole per liter (mmol/L) Standard Deviation 0.354	0.01 Millimole per liter (mmol/L) Standard Deviation 0.308	-0.06 Millimole per liter (mmol/L) Standard Deviation 0.245
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Baseline	137.1 Millimole per liter (mmol/L) Standard Deviation 2.23	136.9 Millimole per liter (mmol/L) Standard Deviation 2.53	138.8 Millimole per liter (mmol/L) Standard Deviation 1.39
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 2	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.26	0.1 Millimole per liter (mmol/L) Standard Deviation 2.30	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.13
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 3	-0.8 Millimole per liter (mmol/L) Standard Deviation 0.98	-0.3 Millimole per liter (mmol/L) Standard Deviation 1.49	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 4	-1.3 Millimole per liter (mmol/L) Standard Deviation 2.25	-0.1 Millimole per liter (mmol/L) Standard Deviation 1.89	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 7	0.5 Millimole per liter (mmol/L) Standard Deviation 2.20	0.8 Millimole per liter (mmol/L) Standard Deviation 1.98	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.77
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 8	0.3 Millimole per liter (mmol/L) Standard Deviation 1.51	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 10	4.5 Millimole per liter (mmol/L) Standard Deviation 4.95	—	—
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 14	1.0 Millimole per liter (mmol/L) Standard Deviation 2.88	0.6 Millimole per liter (mmol/L) Standard Deviation 1.85	-1.3 Millimole per liter (mmol/L) Standard Deviation 1.39
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 4	1.0 Millimole per liter (mmol/L) Standard Deviation 2.45	0.9 Millimole per liter (mmol/L) Standard Deviation 1.64	-0.9 Millimole per liter (mmol/L) Standard Deviation 2.17
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 16	1.0 Millimole per liter (mmol/L) Standard Deviation 2.51	1.3 Millimole per liter (mmol/L) Standard Deviation 1.60	-0.8 Millimole per liter (mmol/L) Standard Deviation 1.58
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 24	0.1 Millimole per liter (mmol/L) Standard Deviation 3.48	2.0 Millimole per liter (mmol/L) Standard Deviation 2.24	-1.1 Millimole per liter (mmol/L) Standard Deviation 2.53

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 14	4.4 International Units per liter (IU/L) Standard Deviation 4.17	2.8 International Units per liter (IU/L) Standard Deviation 4.71	7.6 International Units per liter (IU/L) Standard Deviation 2.97
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Baseline	12.5 International Units per liter (IU/L) Standard Deviation 4.00	20.0 International Units per liter (IU/L) Standard Deviation 8.09	11.8 International Units per liter (IU/L) Standard Deviation 2.71
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 2	-0.5 International Units per liter (IU/L) Standard Deviation 1.31	-1.8 International Units per liter (IU/L) Standard Deviation 3.45	0.6 International Units per liter (IU/L) Standard Deviation 1.69
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 3	0.5 International Units per liter (IU/L) Standard Deviation 1.52	-1.1 International Units per liter (IU/L) Standard Deviation 4.61	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 4	0.5 International Units per liter (IU/L) Standard Deviation 2.43	-0.8 International Units per liter (IU/L) Standard Deviation 6.14	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 7	0.5 International Units per liter (IU/L) Standard Deviation 2.73	2.0 International Units per liter (IU/L) Standard Deviation 7.91	1.5 International Units per liter (IU/L) Standard Deviation 2.83
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 8	0.8 International Units per liter (IU/L) Standard Deviation 3.76	—	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 10	-1.0 International Units per liter (IU/L) Standard Deviation 1.41	—	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 14	0.6 International Units per liter (IU/L) Standard Deviation 2.13	-2.0 International Units per liter (IU/L) Standard Deviation 5.81	1.0 International Units per liter (IU/L) Standard Deviation 1.41
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 4	1.6 International Units per liter (IU/L) Standard Deviation 3.66	-1.9 International Units per liter (IU/L) Standard Deviation 8.18	4.3 International Units per liter (IU/L) Standard Deviation 6.34
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 16	1.4 International Units per liter (IU/L) Standard Deviation 2.45	-0.1 International Units per liter (IU/L) Standard Deviation 7.06	4.4 International Units per liter (IU/L) Standard Deviation 2.72
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 24	1.3 International Units per liter (IU/L) Standard Deviation 5.70	-1.3 International Units per liter (IU/L) Standard Deviation 5.96	2.0 International Units per liter (IU/L) Standard Deviation 4.44
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Baseline	16.0 International Units per liter (IU/L) Standard Deviation 2.98	18.1 International Units per liter (IU/L) Standard Deviation 2.64	14.5 International Units per liter (IU/L) Standard Deviation 2.39
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 2	1.4 International Units per liter (IU/L) Standard Deviation 1.77	-1.8 International Units per liter (IU/L) Standard Deviation 3.06	0.4 International Units per liter (IU/L) Standard Deviation 2.00
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 3	2.7 International Units per liter (IU/L) Standard Deviation 1.63	-0.6 International Units per liter (IU/L) Standard Deviation 3.42	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 4	1.8 International Units per liter (IU/L) Standard Deviation 1.72	0.5 International Units per liter (IU/L) Standard Deviation 3.66	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 7	0.8 International Units per liter (IU/L) Standard Deviation 3.06	2.5 International Units per liter (IU/L) Standard Deviation 3.74	2.8 International Units per liter (IU/L) Standard Deviation 2.82
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 8	1.0 International Units per liter (IU/L) Standard Deviation 3.03	—	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 10	-2.5 International Units per liter (IU/L) Standard Deviation 0.71	—	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 14	1.8 International Units per liter (IU/L) Standard Deviation 2.76	-0.9 International Units per liter (IU/L) Standard Deviation 3.40	1.9 International Units per liter (IU/L) Standard Deviation 2.03
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 4	4.3 International Units per liter (IU/L) Standard Deviation 8.96	0.0 International Units per liter (IU/L) Standard Deviation 4.38	3.0 International Units per liter (IU/L) Standard Deviation 3.51
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 16	1.1 International Units per liter (IU/L) Standard Deviation 3.14	0.4 International Units per liter (IU/L) Standard Deviation 3.95	2.9 International Units per liter (IU/L) Standard Deviation 1.81
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 24	0.1 International Units per liter (IU/L) Standard Deviation 2.47	-0.7 International Units per liter (IU/L) Standard Deviation 2.63	2.0 International Units per liter (IU/L) Standard Deviation 4.78
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Baseline	55.9 International Units per liter (IU/L) Standard Deviation 20.00	57.1 International Units per liter (IU/L) Standard Deviation 9.30	54.6 International Units per liter (IU/L) Standard Deviation 8.99
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 2	0.6 International Units per liter (IU/L) Standard Deviation 4.50	-2.4 International Units per liter (IU/L) Standard Deviation 4.44	2.9 International Units per liter (IU/L) Standard Deviation 3.83
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Week 4	7.9 International Units per liter (IU/L) Standard Deviation 4.52	-1.8 International Units per liter (IU/L) Standard Deviation 2.76	0.6 International Units per liter (IU/L) Standard Deviation 6.50
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 3	4.7 International Units per liter (IU/L) Standard Deviation 4.03	0.0 International Units per liter (IU/L) Standard Deviation 4.81	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 4	4.0 International Units per liter (IU/L) Standard Deviation 5.83	3.0 International Units per liter (IU/L) Standard Deviation 3.89	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 7	5.9 International Units per liter (IU/L) Standard Deviation 4.05	4.9 International Units per liter (IU/L) Standard Deviation 5.33	4.6 International Units per liter (IU/L) Standard Deviation 2.77
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Week 16	5.4 International Units per liter (IU/L) Standard Deviation 5.42	1.0 International Units per liter (IU/L) Standard Deviation 5.39	4.8 International Units per liter (IU/L) Standard Deviation 5.23
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Week 24	3.3 International Units per liter (IU/L) Standard Deviation 5.85	1.6 International Units per liter (IU/L) Standard Deviation 4.89	-0.1 International Units per liter (IU/L) Standard Deviation 5.17
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 8	6.8 International Units per liter (IU/L) Standard Deviation 5.04	—	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 10	-1.5 International Units per liter (IU/L) Standard Deviation 4.95	—	—

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Pulse Rate Baseline	71.1 Beats per minute (Beats/min) Standard Deviation 7.16	75.9 Beats per minute (Beats/min) Standard Deviation 12.26	73.9 Beats per minute (Beats/min) Standard Deviation 7.85
Change From Baseline in Pulse Rate Day 2	-7.6 Beats per minute (Beats/min) Standard Deviation 8.28	-13.8 Beats per minute (Beats/min) Standard Deviation 10.66	-4.4 Beats per minute (Beats/min) Standard Deviation 6.74
Change From Baseline in Pulse Rate Day 3	-5.4 Beats per minute (Beats/min) Standard Deviation 9.01	-12.1 Beats per minute (Beats/min) Standard Deviation 8.63	-7.6 Beats per minute (Beats/min) Standard Deviation 4.84
Change From Baseline in Pulse Rate Day 4	-4.3 Beats per minute (Beats/min) Standard Deviation 8.75	-8.1 Beats per minute (Beats/min) Standard Deviation 11.52	-6.4 Beats per minute (Beats/min) Standard Deviation 7.76
Change From Baseline in Pulse Rate Day 7	-9.4 Beats per minute (Beats/min) Standard Deviation 6.95	-8.4 Beats per minute (Beats/min) Standard Deviation 14.81	-1.4 Beats per minute (Beats/min) Standard Deviation 18.68
Change From Baseline in Pulse Rate Day 8	-8.3 Beats per minute (Beats/min) Standard Deviation 5.78	—	—
Change From Baseline in Pulse Rate Day 10	-12.0 Beats per minute (Beats/min) Standard Deviation 7.07	—	—
Change From Baseline in Pulse Rate Day 14	-10.0 Beats per minute (Beats/min) Standard Deviation 6.72	-11.4 Beats per minute (Beats/min) Standard Deviation 16.95	-4.5 Beats per minute (Beats/min) Standard Deviation 7.60
Change From Baseline in Pulse Rate Day 21	-9.1 Beats per minute (Beats/min) Standard Deviation 5.06	-11.0 Beats per minute (Beats/min) Standard Deviation 18.45	-3.1 Beats per minute (Beats/min) Standard Deviation 11.43
Change From Baseline in Pulse Rate Week 4	-9.9 Beats per minute (Beats/min) Standard Deviation 7.34	-13.4 Beats per minute (Beats/min) Standard Deviation 12.05	-7.3 Beats per minute (Beats/min) Standard Deviation 3.28
Change From Baseline in Pulse Rate Week 8	-8.0 Beats per minute (Beats/min) Standard Deviation 8.09	-8.3 Beats per minute (Beats/min) Standard Deviation 15.75	-3.9 Beats per minute (Beats/min) Standard Deviation 15.13
Change From Baseline in Pulse Rate Week 12	-6.3 Beats per minute (Beats/min) Standard Deviation 7.44	-9.8 Beats per minute (Beats/min) Standard Deviation 14.21	-4.8 Beats per minute (Beats/min) Standard Deviation 10.44
Change From Baseline in Pulse Rate Week 16	-5.1 Beats per minute (Beats/min) Standard Deviation 8.61	-10.6 Beats per minute (Beats/min) Standard Deviation 10.66	-11.1 Beats per minute (Beats/min) Standard Deviation 10.25
Change From Baseline in Pulse Rate Week 20	-5.0 Beats per minute (Beats/min) Standard Deviation 5.01	-12.4 Beats per minute (Beats/min) Standard Deviation 8.06	-9.0 Beats per minute (Beats/min) Standard Deviation 8.14
Change From Baseline in Pulse Rate Week 24	-4.3 Beats per minute (Beats/min) Standard Deviation 4.80	-15.3 Beats per minute (Beats/min) Standard Deviation 11.50	-10.5 Beats per minute (Beats/min) Standard Deviation 6.57

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Respiratory Rate Day 2	-2.0 Breaths per minute (Breaths/min) Standard Deviation 3.85	1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12	-1.3 Breaths per minute (Breaths/min) Standard Deviation 3.20
Change From Baseline in Respiratory Rate Day 8	-0.8 Breaths per minute (Breaths/min) Standard Deviation 5.01	—	—
Change From Baseline in Respiratory Rate Day 10	0.0 Breaths per minute (Breaths/min) Standard Deviation 5.66	—	—
Change From Baseline in Respiratory Rate Day 14	-2.0 Breaths per minute (Breaths/min) Standard Deviation 3.38	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12	-1.5 Breaths per minute (Breaths/min) Standard Deviation 2.98
Change From Baseline in Respiratory Rate Day 21	-2.3 Breaths per minute (Breaths/min) Standard Deviation 2.92	1.0 Breaths per minute (Breaths/min) Standard Deviation 3.85	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.60
Change From Baseline in Respiratory Rate Week 4	-2.0 Breaths per minute (Breaths/min) Standard Deviation 4.41	1.0 Breaths per minute (Breaths/min) Standard Deviation 2.83	1.3 Breaths per minute (Breaths/min) Standard Deviation 2.38
Change From Baseline in Respiratory Rate Week 8	-2.3 Breaths per minute (Breaths/min) Standard Deviation 4.59	1.3 Breaths per minute (Breaths/min) Standard Deviation 1.83	1.0 Breaths per minute (Breaths/min) Standard Deviation 2.83
Change From Baseline in Respiratory Rate Day 3	-1.5 Breaths per minute (Breaths/min) Standard Deviation 4.24	2.3 Breaths per minute (Breaths/min) Standard Deviation 2.71	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12
Change From Baseline in Respiratory Rate Baseline	15.8 Breaths per minute (Breaths/min) Standard Deviation 3.77	13.8 Breaths per minute (Breaths/min) Standard Deviation 1.98	15.5 Breaths per minute (Breaths/min) Standard Deviation 1.41
Change From Baseline in Respiratory Rate Day 1/4 Hours Postdose	-0.3 Breaths per minute (Breaths/min) Standard Deviation 3.45	2.0 Breaths per minute (Breaths/min) Standard Deviation 3.38	-1.4 Breaths per minute (Breaths/min) Standard Deviation 1.90
Change From Baseline in Respiratory Rate Day 1/8 Hours Postdose	-2.3 Breaths per minute (Breaths/min) Standard Deviation 2.25	0.8 Breaths per minute (Breaths/min) Standard Deviation 3.85	1.5 Breaths per minute (Breaths/min) Standard Deviation 2.56
Change From Baseline in Respiratory Rate Day 4	-1.5 Breaths per minute (Breaths/min) Standard Deviation 3.16	0.0 Breaths per minute (Breaths/min) Standard Deviation 2.62	-2.0 Breaths per minute (Breaths/min) Standard Deviation 2.14
Change From Baseline in Respiratory Rate Day 7	-2.8 Breaths per minute (Breaths/min) Standard Deviation 4.89	-0.3 Breaths per minute (Breaths/min) Standard Deviation 2.92	0.8 Breaths per minute (Breaths/min) Standard Deviation 4.77
Change From Baseline in Respiratory Rate Week 12	-2.5 Breaths per minute (Breaths/min) Standard Deviation 3.34	1.5 Breaths per minute (Breaths/min) Standard Deviation 2.33	-1.0 Breaths per minute (Breaths/min) Standard Deviation 2.14
Change From Baseline in Respiratory Rate Week 16	-2.5 Breaths per minute (Breaths/min) Standard Deviation 5.42	3.1 Breaths per minute (Breaths/min) Standard Deviation 1.95	-2.0 Breaths per minute (Breaths/min) Standard Deviation 4.28
Change From Baseline in Respiratory Rate Week 20	-1.0 Breaths per minute (Breaths/min) Standard Deviation 3.21	1.1 Breaths per minute (Breaths/min) Standard Deviation 3.98	-0.9 Breaths per minute (Breaths/min) Standard Deviation 3.80
Change From Baseline in Respiratory Rate Week 24	-2.5 Breaths per minute (Breaths/min) Standard Deviation 1.77	0.3 Breaths per minute (Breaths/min) Standard Deviation 2.93	-3.3 Breaths per minute (Breaths/min) Standard Deviation 2.38

Measure	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 Participants Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 Participants Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 16	9.1 Millimeters of mercury (mmHg) Standard Deviation 5.11	8.4 Millimeters of mercury (mmHg) Standard Deviation 6.73	3.8 Millimeters of mercury (mmHg) Standard Deviation 3.15
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 20	6.3 Millimeters of mercury (mmHg) Standard Deviation 5.55	13.6 Millimeters of mercury (mmHg) Standard Deviation 6.19	-2.0 Millimeters of mercury (mmHg) Standard Deviation 7.09
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 24	7.4 Millimeters of mercury (mmHg) Standard Deviation 6.57	12.1 Millimeters of mercury (mmHg) Standard Deviation 7.49	1.5 Millimeters of mercury (mmHg) Standard Deviation 4.28
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 21	10.6 Millimeters of mercury (mmHg) Standard Deviation 8.37	12.9 Millimeters of mercury (mmHg) Standard Deviation 4.67	2.8 Millimeters of mercury (mmHg) Standard Deviation 6.50
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 4	8.1 Millimeters of mercury (mmHg) Standard Deviation 6.40	7.6 Millimeters of mercury (mmHg) Standard Deviation 6.32	2.1 Millimeters of mercury (mmHg) Standard Deviation 7.24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 8	9.1 Millimeters of mercury (mmHg) Standard Deviation 3.44	7.6 Millimeters of mercury (mmHg) Standard Deviation 3.29	6.4 Millimeters of mercury (mmHg) Standard Deviation 7.74
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 12	6.8 Millimeters of mercury (mmHg) Standard Deviation 7.15	11.5 Millimeters of mercury (mmHg) Standard Deviation 7.78	0.5 Millimeters of mercury (mmHg) Standard Deviation 4.96
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Baseline	106.3 Millimeters of mercury (mmHg) Standard Deviation 11.68	114.4 Millimeters of mercury (mmHg) Standard Deviation 9.50	112.8 Millimeters of mercury (mmHg) Standard Deviation 12.67
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 2	3.5 Millimeters of mercury (mmHg) Standard Deviation 8.04	-4.5 Millimeters of mercury (mmHg) Standard Deviation 7.19	-4.1 Millimeters of mercury (mmHg) Standard Deviation 12.24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 3	0.8 Millimeters of mercury (mmHg) Standard Deviation 5.99	-4.5 Millimeters of mercury (mmHg) Standard Deviation 4.66	-2.9 Millimeters of mercury (mmHg) Standard Deviation 7.49
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 4	0.3 Millimeters of mercury (mmHg) Standard Deviation 6.45	-5.6 Millimeters of mercury (mmHg) Standard Deviation 6.23	-0.5 Millimeters of mercury (mmHg) Standard Deviation 9.20
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 7	2.1 Millimeters of mercury (mmHg) Standard Deviation 6.03	3.6 Millimeters of mercury (mmHg) Standard Deviation 8.28	2.1 Millimeters of mercury (mmHg) Standard Deviation 8.18
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 8	-2.4 Millimeters of mercury (mmHg) Standard Deviation 8.47	—	—
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 10	4.5 Millimeters of mercury (mmHg) Standard Deviation 13.44	—	—
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 14	11.3 Millimeters of mercury (mmHg) Standard Deviation 9.19	6.5 Millimeters of mercury (mmHg) Standard Deviation 10.38	2.4 Millimeters of mercury (mmHg) Standard Deviation 8.68
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 21	9.8 Millimeters of mercury (mmHg) Standard Deviation 13.36	7.8 Millimeters of mercury (mmHg) Standard Deviation 11.50	5.4 Millimeters of mercury (mmHg) Standard Deviation 10.21
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 4	9.5 Millimeters of mercury (mmHg) Standard Deviation 11.80	2.8 Millimeters of mercury (mmHg) Standard Deviation 7.85	-0.9 Millimeters of mercury (mmHg) Standard Deviation 8.54
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 8	9.5 Millimeters of mercury (mmHg) Standard Deviation 14.43	5.6 Millimeters of mercury (mmHg) Standard Deviation 7.58	9.0 Millimeters of mercury (mmHg) Standard Deviation 17.02
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 12	4.5 Millimeters of mercury (mmHg) Standard Deviation 16.38	7.9 Millimeters of mercury (mmHg) Standard Deviation 11.54	-3.8 Millimeters of mercury (mmHg) Standard Deviation 4.89
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 16	7.9 Millimeters of mercury (mmHg) Standard Deviation 11.08	-0.3 Millimeters of mercury (mmHg) Standard Deviation 10.27	4.6 Millimeters of mercury (mmHg) Standard Deviation 5.55
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 20	2.1 Millimeters of mercury (mmHg) Standard Deviation 10.83	6.3 Millimeters of mercury (mmHg) Standard Deviation 7.83	-2.1 Millimeters of mercury (mmHg) Standard Deviation 14.28
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 24	6.4 Millimeters of mercury (mmHg) Standard Deviation 10.07	-0.1 Millimeters of mercury (mmHg) Standard Deviation 4.91	2.0 Millimeters of mercury (mmHg) Standard Deviation 7.78
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Baseline	59.8 Millimeters of mercury (mmHg) Standard Deviation 6.45	62.1 Millimeters of mercury (mmHg) Standard Deviation 5.59	66.5 Millimeters of mercury (mmHg) Standard Deviation 9.71
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 2	3.4 Millimeters of mercury (mmHg) Standard Deviation 8.23	-0.5 Millimeters of mercury (mmHg) Standard Deviation 6.89	-1.6 Millimeters of mercury (mmHg) Standard Deviation 5.48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 3	1.1 Millimeters of mercury (mmHg) Standard Deviation 7.24	-1.9 Millimeters of mercury (mmHg) Standard Deviation 5.51	2.4 Millimeters of mercury (mmHg) Standard Deviation 4.87
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 4	-2.3 Millimeters of mercury (mmHg) Standard Deviation 4.62	-0.8 Millimeters of mercury (mmHg) Standard Deviation 4.86	0.6 Millimeters of mercury (mmHg) Standard Deviation 6.05
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 7	-1.6 Millimeters of mercury (mmHg) Standard Deviation 4.41	9.5 Millimeters of mercury (mmHg) Standard Deviation 9.78	1.9 Millimeters of mercury (mmHg) Standard Deviation 8.32
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 8	-1.8 Millimeters of mercury (mmHg) Standard Deviation 3.96	—	—
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 10	9.0 Millimeters of mercury (mmHg) Standard Deviation 8.49	—	—
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 14	6.1 Millimeters of mercury (mmHg) Standard Deviation 3.72	6.1 Millimeters of mercury (mmHg) Standard Deviation 5.33	1.6 Millimeters of mercury (mmHg) Standard Deviation 6.63

Measure	Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] n=8 participants at risk Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.	Part 2 Group: VH3810109 60 mg/kg [IV] n=8 participants at risk Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=8 participants at risk Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.
General disorders Injection site erythema	87.5% 7/8 • Number of events 7 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	100.0% 8/8 • Number of events 8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Infections and infestations Upper respiratory tract infection	25.0% 2/8 • Number of events 2 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Injection site pain	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	25.0% 2/8 • Number of events 2 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Injection site pruritus	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Musculoskeletal and connective tissue disorders Muscle tightness	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Nervous system disorders Paraesthesia	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Injury, poisoning and procedural complications Post-traumatic pain	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Nervous system disorders Presyncope	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Infections and infestations Viral infection	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Medical device site dermatitis	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Injection site bruising	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	25.0% 2/8 • Number of events 2 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Infections and infestations Nasopharyngitis	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	25.0% 2/8 • Number of events 2 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Infections and infestations COVID-19	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
Gastrointestinal disorders Flatulence	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Injection site induration	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.
General disorders Injection site warmth	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	0.00% 0/8 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.	12.5% 1/8 • Number of events 1 • SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.