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=5 Participants	40.0 Years STANDARD_DEVIATION 14.45 • n=7 Participants	39.9 Years STANDARD_DEVIATION 10.59 • n=5 Participants	40.87 Years STANDARD_DEVIATION 10.85 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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 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 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 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.
Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)	7 Participants	8 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 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 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 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.
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 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 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 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.
Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)	7 Participants	8 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 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 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 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.
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	—
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	—

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 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 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 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.
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 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 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 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.
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 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 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 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.
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 3	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 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 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 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.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109	7587 Daymicrogram/mililitre (dayμg/mL) Interval 4789.0 to 10380.0	31560 Daymicrogram/mililitre (dayμg/mL) Interval 27620.0 to 35490.0	12840 Daymicrogram/mililitre (dayμg/mL) Interval 8883.0 to 16800.0

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 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 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 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.
AUC From Time Zero to Time t (AUC[0-t]) of VH3810109	6996 day*μg/mL Interval 4512.0 to 9479.0	29160 day*μg/mL Interval 25550.0 to 32770.0	11590 day*μg/mL Interval 7819.0 to 15360.0

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 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 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 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.
Maximum Observed Concentration (Cmax) of VH3810109	148.2 μg/mL Interval 117.3 to 179.1	1864 μg/mL Interval 1620.0 to 2107.0	321.1 μg/mL Interval 201.6 to 440.6

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 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 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 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.
Time of Maximum Observed Concentration (Tmax) of VH3810109	4.503 Days Interval 1.472 to 7.535	0.046 Days Interval 0.045 to 0.047	2.882 Days Interval 2.586 to 3.178

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 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 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 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.
Apparent Terminal Phase Half-life (t1/2) of VH3810109	38.17 Days Interval 23.41 to 52.93	46.97 Days Interval 40.86 to 53.09	44.95 Days Interval 34.14 to 55.76

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 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 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 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.
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 1.050	1.44 Scores on a scale Standard Deviation 0.496	—
Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) Acceptance of ISRs, Day 7	1.44 Scores on a scale Standard Deviation 0.729	1.50 Scores on a scale Standard Deviation 0.802	—

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 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 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 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.
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 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 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 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.
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	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) 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	6 Participants	4 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 2	7 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 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) Moderately 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) A little 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) 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	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 2	1 Participants	4 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	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) 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	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 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	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) 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 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 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 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.
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 1	3.63 Scores on a scale Standard Deviation 2.326	2.75 Scores on a scale Standard Deviation 2.550	—
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 2	3.63 Scores on a scale Standard Deviation 2.615	0.63 Scores on a scale Standard Deviation 0.744	—
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3) Day 7	3.63 Scores on a scale Standard Deviation 2.925	0.38 Scores on a scale Standard Deviation 0.744	—

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 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 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 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.
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 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.	Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] n=18 Number of events 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 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.
Number of ISRs Events Overall and by Grade (Part 1 and 3) Overall ISRs	14 Number of events	18 Number of events	—
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 1 ISRs	2 Number of events	6 Number of events	—
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 2 ISRs	5 Number of events	2 Number of events	—
Number of ISRs Events Overall and by Grade (Part 1 and 3) Grade 3 ISRs	7 Number of events	10 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 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 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 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.
The Overall Duration of ISRs, Expressed in Days	2.9 Days Standard Deviation 1.35	4.6 Days Standard Deviation 6.29	—

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 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 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 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.
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Day 2	0.006 10^9 cells/L Standard Deviation 0.1908	-0.484 10^9 cells/L Standard Deviation 0.3503	-0.094 10^9 cells/L Standard Deviation 0.2147
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	-0.043 10^9 cells/L Standard Deviation 0.1763	-0.211 10^9 cells/L Standard Deviation 0.3189	-0.175 10^9 cells/L Standard Deviation 0.3166
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Baseline	0.033 10^9 cells/L Standard Deviation 0.0139	0.035 10^9 cells/L Standard Deviation 0.0207	0.044 10^9 cells/L Standard Deviation 0.0106
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Day 2	-0.004 10^9 cells/L Standard Deviation 0.0092	0.000 10^9 cells/L Standard Deviation 0.0151	-0.009 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 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	0.008 10^9 cells/L Standard Deviation 0.0128	0.003 10^9 cells/L Standard Deviation 0.0128	-0.005 10^9 cells/L Standard Deviation 0.0107
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	0.001 10^9 cells/L Standard Deviation 0.0064	0.008 10^9 cells/L Standard Deviation 0.0139	0.003 10^9 cells/L Standard Deviation 0.0149
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 4	0.003 10^9 cells/L Standard Deviation 0.0139	0.004 10^9 cells/L Standard Deviation 0.0141	0.000 10^9 cells/L Standard Deviation 0.0185
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 16	-0.001 10^9 cells/L Standard Deviation 0.0083	0.004 10^9 cells/L Standard Deviation 0.0192	-0.001 10^9 cells/L Standard Deviation 0.0121
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils, at Week 24	0.000 10^9 cells/L Standard Deviation 0.0151	0.001 10^9 cells/L Standard Deviation 0.0259	-0.013 10^9 cells/L Standard Deviation 0.0160
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Baseline	0.121 10^9 cells/L Standard Deviation 0.0957	0.098 10^9 cells/L Standard Deviation 0.0333	0.145 10^9 cells/L Standard Deviation 0.1370
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Day 2	0.018 10^9 cells/L Standard Deviation 0.0851	0.010 10^9 cells/L Standard Deviation 0.0151	0.016 10^9 cells/L Standard Deviation 0.0385
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	0.016 10^9 cells/L Standard Deviation 0.0964	0.000 10^9 cells/L Standard Deviation 0.0293	0.016 10^9 cells/L Standard Deviation 0.0619
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	0.059 10^9 cells/L Standard Deviation 0.0718	0.011 10^9 cells/L Standard Deviation 0.0624	0.025 10^9 cells/L Standard Deviation 0.0444
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 4	0.045 10^9 cells/L Standard Deviation 0.0644	0.001 10^9 cells/L Standard Deviation 0.0290	-0.004 10^9 cells/L Standard Deviation 0.0403
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 16	0.059 10^9 cells/L Standard Deviation 0.1667	0.053 10^9 cells/L Standard Deviation 0.1269	0.013 10^9 cells/L Standard Deviation 0.0605
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils, at Week 24	0.001 10^9 cells/L Standard Deviation 0.1063	0.094 10^9 cells/L Standard Deviation 0.1445	-0.001 10^9 cells/L Standard Deviation 0.0527
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Baseline	5.13 10^9 cells/L Standard Deviation 1.161	6.31 10^9 cells/L Standard Deviation 1.365	6.50 10^9 cells/L Standard Deviation 2.036
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Day 2	0.43 10^9 cells/L Standard Deviation 0.696	-0.31 10^9 cells/L Standard Deviation 1.253	-0.36 10^9 cells/L Standard Deviation 0.980
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 Day 7	0.11 10^9 cells/L Standard Deviation 0.872	-0.04 10^9 cells/L Standard Deviation 1.171	-0.25 10^9 cells/L Standard Deviation 2.165
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	-0.26 10^9 cells/L Standard Deviation 0.809	-0.38 10^9 cells/L Standard Deviation 0.791	-0.25 10^9 cells/L Standard Deviation 0.994
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 4	-0.03 10^9 cells/L Standard Deviation 1.261	-0.40 10^9 cells/L Standard Deviation 0.857	-0.48 10^9 cells/L Standard Deviation 1.340
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 16	0.01 10^9 cells/L Standard Deviation 0.892	-0.63 10^9 cells/L Standard Deviation 1.073	-0.64 10^9 cells/L Standard Deviation 1.162
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC, at Week 24	-0.46 10^9 cells/L Standard Deviation 0.883	0.40 10^9 cells/L Standard Deviation 2.438	-0.51 10^9 cells/L Standard Deviation 0.540
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Baseline	1.368 10^9 cells/L Standard Deviation 0.2680	2.214 10^9 cells/L Standard Deviation 0.5545	2.086 10^9 cells/L Standard Deviation 0.4824
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	-0.019 10^9 cells/L Standard Deviation 0.1664	-0.386 10^9 cells/L Standard Deviation 0.3366	-0.161 10^9 cells/L Standard Deviation 0.3561
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 4	0.063 10^9 cells/L Standard Deviation 0.1943	-0.314 10^9 cells/L Standard Deviation 0.2911	-0.226 10^9 cells/L Standard Deviation 0.2908
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 16	0.100 10^9 cells/L Standard Deviation 0.2441	-0.190 10^9 cells/L Standard Deviation 0.2478	-0.191 10^9 cells/L Standard Deviation 0.3559
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes, at Week 24	0.058 10^9 cells/L Standard Deviation 0.3377	-0.380 10^9 cells/L Standard Deviation 0.3497	-0.339 10^9 cells/L Standard Deviation 0.4461
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Baseline	0.396 10^9 cells/L Standard Deviation 0.1556	0.461 10^9 cells/L Standard Deviation 0.1038	0.485 10^9 cells/L Standard Deviation 0.1488
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Day 2	0.091 10^9 cells/L Standard Deviation 0.1037	-0.048 10^9 cells/L Standard Deviation 0.1159	-0.008 10^9 cells/L Standard Deviation 0.0587
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	0.049 10^9 cells/L Standard Deviation 0.1185	-0.021 10^9 cells/L Standard Deviation 0.1572	-0.013 10^9 cells/L Standard Deviation 0.1413
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	0.034 10^9 cells/L Standard Deviation 0.1347	-0.078 10^9 cells/L Standard Deviation 0.1237	-0.015 10^9 cells/L Standard Deviation 0.1319
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 4	0.036 10^9 cells/L Standard Deviation 0.1061	-0.045 10^9 cells/L Standard Deviation 0.1146	-0.034 10^9 cells/L Standard Deviation 0.1010
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 16	0.023 10^9 cells/L Standard Deviation 0.0630	-0.029 10^9 cells/L Standard Deviation 0.1221	0.001 10^9 cells/L Standard Deviation 0.0724
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes, at Week 24	-0.018 10^9 cells/L Standard Deviation 0.1099	0.001 10^9 cells/L Standard Deviation 0.1670	-0.020 10^9 cells/L Standard Deviation 0.0462
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Baseline	3.218 10^9 cells/L Standard Deviation 0.9157	3.499 10^9 cells/L Standard Deviation 0.9783	3.756 10^9 cells/L Standard Deviation 1.6757
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Day 2	0.315 10^9 cells/L Standard Deviation 0.8333	0.214 10^9 cells/L Standard Deviation 1.0869	-0.263 10^9 cells/L Standard Deviation 0.9093
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 7	0.066 10^9 cells/L Standard Deviation 0.8177	0.210 10^9 cells/L Standard Deviation 0.9063	-0.079 10^9 cells/L Standard Deviation 1.8480
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 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	-0.340 10^9 cells/L Standard Deviation 0.7531	0.096 10^9 cells/L Standard Deviation 0.8912	-0.116 10^9 cells/L Standard Deviation 0.7571
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 4	-0.160 10^9 cells/L Standard Deviation 1.2887	-0.036 10^9 cells/L Standard Deviation 0.9269	-0.233 10^9 cells/L Standard Deviation 1.1531
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 16	-0.178 10^9 cells/L Standard Deviation 0.6481	-0.468 10^9 cells/L Standard Deviation 0.9437	-0.500 10^9 cells/L Standard Deviation 0.9401
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils, at Week 24	-0.535 10^9 cells/L Standard Deviation 0.8511	0.691 10^9 cells/L Standard Deviation 2.3541	-0.160 10^9 cells/L Standard Deviation 0.6340
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Baseline	256.3 10^9 cells/L Standard Deviation 48.96	301.9 10^9 cells/L Standard Deviation 34.84	289.5 10^9 cells/L Standard Deviation 71.95
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Day 2	6.6 10^9 cells/L Standard Deviation 12.70	-14.6 10^9 cells/L Standard Deviation 12.95	1.0 10^9 cells/L Standard Deviation 18.48
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 Platelets, at Day 7	1.4 10^9 cells/L Standard Deviation 13.65	0.0 10^9 cells/L Standard Deviation 13.49	1.9 10^9 cells/L Standard Deviation 23.46
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	19.9 10^9 cells/L Standard Deviation 32.89	1.0 10^9 cells/L Standard Deviation 52.60	2.1 10^9 cells/L Standard Deviation 40.86
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 4	30.6 10^9 cells/L Standard Deviation 87.1	-3.5 10^9 cells/L Standard Deviation 15.10	3.1 10^9 cells/L Standard Deviation 31.31
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 16	-0.5 10^9 cells/L Standard Deviation 19.34	6.6 10^9 cells/L Standard Deviation 35.49	-6.4 10^9 cells/L Standard Deviation 31.43
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelets, at Week 24	1.1 10^9 cells/L Standard Deviation 27.58	12.5 10^9 cells/L Standard Deviation 37.14	-2.3 10^9 cells/L Standard Deviation 27.79

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 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 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 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.
Change From Baseline in Hematocrit Week 16	0.0196 Proportion of red blood cells in blood Standard Deviation 0.02303	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
Change From Baseline in Hematocrit Week 24	0.0119 Proportion of red blood cells in blood Standard Deviation 0.01389	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
Change From Baseline in Hematocrit Baseline	0.3873 Proportion of red blood cells in blood Standard Deviation 0.04541	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
Change From Baseline in Hematocrit Day 2	0.0159 Proportion of red blood cells in blood Standard Deviation 0.02226	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
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	0.0168 Proportion of red blood cells in blood Standard Deviation 0.01662	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
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	0.0118 Proportion of red blood cells in blood Standard Deviation 0.01426	-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
Change From Baseline in Hematocrit Week 4	0.0016 Proportion of red blood cells in blood Standard Deviation 0.01672	-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

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 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 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 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.
Change From Baseline in Red Blood Cell Count (RBC) Day 7	0.155 Trillion cells/L (TI/L) Standard Deviation 0.2067	0.084 Trillion cells/L (TI/L) Standard Deviation 0.1584	-0.074 Trillion cells/L (TI/L) Standard Deviation 0.1429
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	0.130 Trillion cells/L (TI/L) Standard Deviation 0.1646	-0.088 Trillion cells/L (TI/L) Standard Deviation 0.1940	-0.064 Trillion cells/L (TI/L) Standard Deviation 0.1686
Change From Baseline in Red Blood Cell Count (RBC) Week 4	0.050 Trillion cells/L (TI/L) Standard Deviation 0.1802	-0.026 Trillion cells/L (TI/L) Standard Deviation 0.1625	-0.078 Trillion cells/L (TI/L) Standard Deviation 0.1814
Change From Baseline in Red Blood Cell Count (RBC) Week 16	0.186 Trillion cells/L (TI/L) Standard Deviation 0.2612	0.124 Trillion cells/L (TI/L) Standard Deviation 0.2212	-0.164 Trillion cells/L (TI/L) Standard Deviation 0.0752
Change From Baseline in Red Blood Cell Count (RBC) Week 24	0.063 Trillion cells/L (TI/L) Standard Deviation 0.1496	0.078 Trillion cells/L (TI/L) Standard Deviation 0.2326	-0.110 Trillion cells/L (TI/L) Standard Deviation 0.3089
Change From Baseline in Red Blood Cell Count (RBC) Baseline	4.518 Trillion cells/L (TI/L) Standard Deviation 0.5518	4.523 Trillion cells/L (TI/L) Standard Deviation 0.4014	4.889 Trillion cells/L (TI/L) Standard Deviation 0.6362
Change From Baseline in Red Blood Cell Count (RBC) Day 2	0.180 Trillion cells/L (TI/L) Standard Deviation 0.2654	0.043 Trillion cells/L (TI/L) Standard Deviation 0.1717	0.141 Trillion cells/L (TI/L) Standard Deviation 0.2154
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

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 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 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 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.
Change From Baseline in Mean Corpuscle Volume (MCV) Baseline	85.78 cubic microns Standard Deviation 2.013	86.89 cubic microns Standard Deviation 6.081	87.28 cubic microns Standard Deviation 3.478
Change From Baseline in Mean Corpuscle Volume (MCV) Day 2	0.14 cubic microns Standard Deviation 0.466	-0.66 cubic microns Standard Deviation 0.478	-0.03 cubic microns Standard Deviation 0.354
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) Day 7	0.84 cubic microns Standard Deviation 0.661	-0.61 cubic microns Standard Deviation 0.562	-0.10 cubic microns Standard Deviation 0.469
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	0.06 cubic microns Standard Deviation 0.784	0.04 cubic microns Standard Deviation 0.746	0.06 cubic microns Standard Deviation 0.623
Change From Baseline in Mean Corpuscle Volume (MCV) Week 4	-0.53 cubic microns Standard Deviation 1.216	0.34 cubic microns Standard Deviation 1.125	-0.03 cubic microns Standard Deviation 0.703
Change From Baseline in Mean Corpuscle Volume (MCV) Week 16	0.76 cubic microns Standard Deviation 0.842	-0.75 cubic microns Standard Deviation 2.522	0.74 cubic microns Standard Deviation 1.078
Change From Baseline in Mean Corpuscle Volume (MCV) Week 24	1.34 cubic microns Standard Deviation 1.983	-0.41 cubic microns Standard Deviation 2.107	0.40 cubic microns Standard Deviation 2.195

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 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 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 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.
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) Baseline	29.05 picograms (pg) Standard Deviation 1.028	28.33 picograms (pg) Standard Deviation 2.213	29.26 picograms (pg) Standard Deviation 1.660
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 2	0.20 picograms (pg) Standard Deviation 0.553	0.21 picograms (pg) Standard Deviation 0.458	-0.08 picograms (pg) Standard Deviation 0.345
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	-0.36 picograms (pg) Standard Deviation 0.302	0.16 picograms (pg) Standard Deviation 0.385	0.29 picograms (pg) Standard Deviation 0.536
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) Day 10	—	-0.20 picograms (pg) Standard Deviation 0.141	—
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Day 14	-0.06 picograms (pg) Standard Deviation 0.475	0.44 picograms (pg) Standard Deviation 0.524	0.33 picograms (pg) Standard Deviation 0.590
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 4	-0.09 picograms (pg) Standard Deviation 0.608	0.39 picograms (pg) Standard Deviation 0.617	0.16 picograms (pg) Standard Deviation 0.466
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 16	-0.21 picograms (pg) Standard Deviation 0.613	0.39 picograms (pg) Standard Deviation 0.779	0.24 picograms (pg) Standard Deviation 0.737
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Week 24	-0.39 picograms (pg) Standard Deviation 1.051	0.39 picograms (pg) Standard Deviation 0.716	0.31 picograms (pg) Standard Deviation 1.524

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 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 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 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.
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Glucose	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Protein	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline Leukocyte esterase	0 Participants	1 Participants	1 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 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 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 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.
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	0.875 Miliseconds Standard Deviation 3.5587	—	-5.250 Miliseconds Standard Deviation 6.8098
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	-2.292 Miliseconds Standard Deviation 2.6693	-0.458 Miliseconds Standard Deviation 3.7116	-3.708 Miliseconds Standard Deviation 5.6833
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	161.375 Miliseconds Standard Deviation 20.2762	164.000 Miliseconds Standard Deviation 16.6733	164.875 Miliseconds Standard Deviation 14.2872
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	-4.000 Miliseconds Standard Deviation 10.7157	—	0.500 Miliseconds Standard Deviation 4.5145
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	-0.208 Miliseconds Standard Deviation 7.5297	1.917 Miliseconds Standard Deviation 9.5282	3.500 Miliseconds Standard Deviation 7.6677
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	1.083 Miliseconds Standard Deviation 7.8493	3.000 Miliseconds Standard Deviation 10.6354	3.667 Miliseconds Standard Deviation 10.6845
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	4.625 Miliseconds Standard Deviation 8.6179	0.875 Miliseconds Standard Deviation 10.8656	3.000 Miliseconds Standard Deviation 10.0775
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	1.458 Miliseconds Standard Deviation 11.6223	6.167 Miliseconds Standard Deviation 10.9516	2.625 Miliseconds Standard Deviation 6.3507
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	9.542 Miliseconds Standard Deviation 5.9038	4.250 Miliseconds Standard Deviation 11.7700	-2.250 Miliseconds Standard Deviation 10.6231
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	4.583 Miliseconds Standard Deviation 10.1164	-0.958 Miliseconds Standard Deviation 11.6571	-1.905 Miliseconds Standard Deviation 12.0872
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	92.875 Miliseconds Standard Deviation 8.1141	90.750 Miliseconds Standard Deviation 11.8291	100.250 Miliseconds Standard Deviation 12.1155
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	-0.875 Miliseconds Standard Deviation 2.3363	-2.833 Miliseconds Standard Deviation 6.2463	-2.583 Miliseconds Standard Deviation 3.6764
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	1.458 Miliseconds Standard Deviation 5.0895	-1.875 Miliseconds Standard Deviation 6.0708	-4.458 Miliseconds Standard Deviation 6.4855
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	0.000 Miliseconds Standard Deviation 5.1052	-1.500 Miliseconds Standard Deviation 6.8359	-2.917 Miliseconds Standard Deviation 6.3164
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	0.708 Miliseconds Standard Deviation 3.9337	-0.958 Miliseconds Standard Deviation 3.8398	-4.708 Miliseconds Standard Deviation 6.2372
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	-0.917 Miliseconds Standard Deviation 4.5066	-0.458 Miliseconds Standard Deviation 4.4755	-5.238 Miliseconds Standard Deviation 6.4599
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	378.875 Miliseconds Standard Deviation 17.7719	395.875 Miliseconds Standard Deviation 19.1493	380.375 Miliseconds Standard Deviation 12.3513
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	0.708 Miliseconds Standard Deviation 12.1713	—	-0.625 Miliseconds Standard Deviation 8.6620
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	4.750 Miliseconds Standard Deviation 12.1299	20.750 Miliseconds Standard Deviation 18.9684	16.083 Miliseconds Standard Deviation 13.6449
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	8.583 Miliseconds Standard Deviation 18.2650	10.542 Miliseconds Standard Deviation 27.0566	9.792 Miliseconds Standard Deviation 12.7179
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	5.917 Miliseconds Standard Deviation 22.1616	7.000 Miliseconds Standard Deviation 27.0725	9.167 Miliseconds Standard Deviation 18.5267
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	7.042 Miliseconds Standard Deviation 20.7972	21.083 Miliseconds Standard Deviation 21.4755	8.500 Miliseconds Standard Deviation 13.6498
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	14.083 Miliseconds Standard Deviation 18.0614	31.167 Miliseconds Standard Deviation 17.0023	10.583 Miliseconds Standard Deviation 13.7318
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	15.125 Miliseconds Standard Deviation 21.3348	13.167 Miliseconds Standard Deviation 21.5318	15.952 Miliseconds Standard Deviation 10.9771
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	402.750 Miliseconds Standard Deviation 10.5119	419.375 Miliseconds Standard Deviation 13.7523	397.000 Miliseconds Standard Deviation 14.8131
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	2.833 Miliseconds Standard Deviation 10.0570	—	1.375 Miliseconds Standard Deviation 9.1780
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	-1.875 Miliseconds Standard Deviation 9.2923	1.083 Miliseconds Standard Deviation 15.4486	3.375 Miliseconds Standard Deviation 11.7924
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	0.917 Miliseconds Standard Deviation 9.5232	-1.250 Miliseconds Standard Deviation 14.9047	2.083 Miliseconds Standard Deviation 8.6295
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	-2.000 Miliseconds Standard Deviation 15.0449	-4.292 Miliseconds Standard Deviation 18.3220	1.917 Miliseconds Standard Deviation 9.0847
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	8.667 Miliseconds Standard Deviation 22.8341	0.958 Miliseconds Standard Deviation 9.6715	3.500 Miliseconds Standard Deviation 11.9004
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	1.167 Miliseconds Standard Deviation 10.6398	6.500 Miliseconds Standard Deviation 8.8515	2.250 Miliseconds Standard Deviation 8.4867
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	2.417 Miliseconds Standard Deviation 10.5991	2.229 Miliseconds Standard Deviation 14.8754	7.238 Miliseconds Standard Deviation 5.6461

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 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 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 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.
Change From Baseline in Temperature Baseline	36.54 Degrees Celcius Standard Deviation 0.233	36.79 Degrees Celcius Standard Deviation 0.344	36.49 Degrees Celcius Standard Deviation 0.500
Change From Baseline in Temperature Day 2	-0.10 Degrees Celcius Standard Deviation 0.424	-0.48 Degrees Celcius Standard Deviation 0.437	-0.14 Degrees Celcius Standard Deviation 0.342
Change From Baseline in Temperature Day 3	-0.23 Degrees Celcius Standard Deviation 0.365	-0.50 Degrees Celcius Standard Deviation 0.475	-0.25 Degrees Celcius Standard Deviation 0.454
Change From Baseline in Temperature Day 4	-0.03 Degrees Celcius Standard Deviation 0.311	-0.41 Degrees Celcius Standard Deviation 0.569	-0.20 Degrees Celcius Standard Deviation 0.463
Change From Baseline in Temperature Day 7	-0.05 Degrees Celcius Standard Deviation 0.524	-0.41 Degrees Celcius Standard Deviation 0.622	-0.04 Degrees Celcius Standard Deviation 0.578
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	-0.13 Degrees Celcius Standard Deviation 0.392	-0.28 Degrees Celcius Standard Deviation 0.492	-0.28 Degrees Celcius Standard Deviation 0.453
Change From Baseline in Temperature Day 21	-0.11 Degrees Celcius Standard Deviation 0.554	-0.49 Degrees Celcius Standard Deviation 0.352	-0.04 Degrees Celcius Standard Deviation 0.469
Change From Baseline in Temperature Week 4	-0.21 Degrees Celcius Standard Deviation 0.364	-0.56 Degrees Celcius Standard Deviation 0.534	-0.09 Degrees Celcius Standard Deviation 0.549
Change From Baseline in Temperature Week 8	-0.28 Degrees Celcius Standard Deviation 0.399	-0.45 Degrees Celcius Standard Deviation 0.535	-0.20 Degrees Celcius Standard Deviation 0.566
Change From Baseline in Temperature Week 12	-0.23 Degrees Celcius Standard Deviation 0.271	-0.33 Degrees Celcius Standard Deviation 0.607	-0.28 Degrees Celcius Standard Deviation 0.423
Change From Baseline in Temperature Week 16	-0.34 Degrees Celcius Standard Deviation 0.346	-0.33 Degrees Celcius Standard Deviation 0.575	-0.69 Degrees Celcius Standard Deviation 0.534
Change From Baseline in Temperature Week 20	-0.17 Degrees Celcius Standard Deviation 0.315	-0.40 Degrees Celcius Standard Deviation 0.414	-0.19 Degrees Celcius Standard Deviation 0.505
Change From Baseline in Temperature Week 24	-0.19 Degrees Celcius Standard Deviation 0.364	-0.55 Degrees Celcius Standard Deviation 0.678	0.09 Degrees Celcius Standard Deviation 0.367

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 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 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 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.
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Baseline	70.0 Grams per liter (g/L) Standard Deviation 3.85	71.0 Grams per liter (g/L) Standard Deviation 3.66	72.3 Grams per liter (g/L) Standard Deviation 4.40
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 24	-3.4 Grams per liter (g/L) Standard Deviation 3.96	0.1 Grams per liter (g/L) Standard Deviation 2.17	-2.7 Grams per liter (g/L) Standard Deviation 4.46
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Baseline	131.4 Grams per liter (g/L) Standard Deviation 16.78	128.3 Grams per liter (g/L) Standard Deviation 15.83	142.4 Grams per liter (g/L) Standard Deviation 15.67
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Day 2	5.8 Grams per liter (g/L) Standard Deviation 6.90	1.9 Grams per liter (g/L) Standard Deviation 4.61	3.9 Grams per liter (g/L) Standard Deviation 6.49
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	2.6 Grams per liter (g/L) Standard Deviation 6.35	2.9 Grams per liter (g/L) Standard Deviation 5.28	-0.4 Grams per liter (g/L) Standard Deviation 4.37
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	3.4 Grams per liter (g/L) Standard Deviation 4.78	-0.8 Grams per liter (g/L) Standard Deviation 5.90	-0.4 Grams per liter (g/L) Standard Deviation 4.47
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 4	1.0 Grams per liter (g/L) Standard Deviation 5.29	0.4 Grams per liter (g/L) Standard Deviation 6.55	-1.4 Grams per liter (g/L) Standard Deviation 4.96
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 16	4.3 Grams per liter (g/L) Standard Deviation 7.23	5.3 Grams per liter (g/L) Standard Deviation 8.01	-3.4 Grams per liter (g/L) Standard Deviation 4.12
Change From Baseline in Hemoglobin, Albumin and Total Protein Hemoglobin, at Week 24	0.4 Grams per liter (g/L) Standard Deviation 4.07	4.0 Grams per liter (g/L) Standard Deviation 7.54	-1.4 Grams per liter (g/L) Standard Deviation 13.99
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Baseline	44.0 Grams per liter (g/L) Standard Deviation 3.02	43.9 Grams per liter (g/L) Standard Deviation 3.00	43.9 Grams per liter (g/L) Standard Deviation 3.44
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Day 2	0.4 Grams per liter (g/L) Standard Deviation 2.07	-2.4 Grams per liter (g/L) Standard Deviation 2.45	-0.3 Grams per liter (g/L) Standard Deviation 1.83
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	0.1 Grams per liter (g/L) Standard Deviation 2.80	-1.9 Grams per liter (g/L) Standard Deviation 1.81	0.4 Grams per liter (g/L) Standard Deviation 2.00
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	0.0 Grams per liter (g/L) Standard Deviation 2.00	-1.0 Grams per liter (g/L) Standard Deviation 1.51	-0.1 Grams per liter (g/L) Standard Deviation 1.89
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 4	-1.4 Grams per liter (g/L) Standard Deviation 2.56	-0.1 Grams per liter (g/L) Standard Deviation 2.10	-0.3 Grams per liter (g/L) Standard Deviation 2.43
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 16	0.6 Grams per liter (g/L) Standard Deviation 1.77	0.8 Grams per liter (g/L) Standard Deviation 2.19	-2.0 Grams per liter (g/L) Standard Deviation 2.16
Change From Baseline in Hemoglobin, Albumin and Total Protein Albumin, at Week 24	-1.5 Grams per liter (g/L) Standard Deviation 2.14	-0.3 Grams per liter (g/L) Standard Deviation 1.04	-1.9 Grams per liter (g/L) Standard Deviation 2.48
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Day 2	0.6 Grams per liter (g/L) Standard Deviation 4.17	-1.4 Grams per liter (g/L) Standard Deviation 4.17	-1.5 Grams per liter (g/L) Standard Deviation 3.51
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	0.0 Grams per liter (g/L) Standard Deviation 4.57	-2.8 Grams per liter (g/L) Standard Deviation 2.76	-0.1 Grams per liter (g/L) Standard Deviation 3.52
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	0.0 Grams per liter (g/L) Standard Deviation 4.14	-1.6 Grams per liter (g/L) Standard Deviation 2.56	-0.8 Grams per liter (g/L) Standard Deviation 2.71
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 4	-0.6 Grams per liter (g/L) Standard Deviation 3.16	-1.0 Grams per liter (g/L) Standard Deviation 3.38	-1.9 Grams per liter (g/L) Standard Deviation 3.14
Change From Baseline in Hemoglobin, Albumin and Total Protein Total Protein, at Week 16	0.9 Grams per liter (g/L) Standard Deviation 2.42	1.0 Grams per liter (g/L) Standard Deviation 3.85	-4.4 Grams per liter (g/L) Standard Deviation 3.87

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 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 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.
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 4	-1.7528 milligram per deciliter (mg/dL) Standard Deviation 3.77392	-1.1115 milligram per deciliter (mg/dL) Standard Deviation 1.51851	-0.3206 milligram per deciliter (mg/dL) Standard Deviation 3.67145
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	0.180408 milligram per deciliter (mg/dL) Standard Deviation 0.1723749	0.548161 milligram per deciliter (mg/dL) Standard Deviation 1.1531574	0.166530 milligram per deciliter (mg/dL) Standard Deviation 0.3408978
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 Week 24	0.32576 milligram per deciliter (mg/dL) Standard Deviation 1.074638	0.26775 milligram per deciliter (mg/dL) Standard Deviation 1.474420	-0.05610 milligram per deciliter (mg/dL) Standard Deviation 1.187055
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 4	-0.5344 milligram per deciliter (mg/dL) Standard Deviation 0.62287	0.0000 milligram per deciliter (mg/dL) Standard Deviation 0.42872	-0.1496 milligram per deciliter (mg/dL) Standard Deviation 0.50427
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 16	-0.3206 milligram per deciliter (mg/dL) Standard Deviation 0.59544	-0.2138 milligram per deciliter (mg/dL) Standard Deviation 0.52308	-0.7817 milligram per deciliter (mg/dL) Standard Deviation 0.56591
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Baseline	5.009778 milligram per deciliter (mg/dL) Standard Deviation 0.2649736	5.037533 milligram per deciliter (mg/dL) Standard Deviation 0.2582430	4.864064 milligram per deciliter (mg/dL) Standard Deviation 0.2032812
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Day 2	-0.006939 milligram per deciliter (mg/dL) Standard Deviation 0.2306696	0.256734 milligram per deciliter (mg/dL) Standard Deviation 0.5881647	0.145714 milligram per deciliter (mg/dL) Standard Deviation 0.2966207
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 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	-0.027755 milligram per deciliter (mg/dL) Standard Deviation 0.2586688	0.048571 milligram per deciliter (mg/dL) Standard Deviation 0.3884992	0.006939 milligram per deciliter (mg/dL) Standard Deviation 0.2790329
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 4	0.027755 milligram per deciliter (mg/dL) Standard Deviation 0.3857275	-0.124898 milligram per deciliter (mg/dL) Standard Deviation 0.2842106	0.215101 milligram per deciliter (mg/dL) Standard Deviation 0.5168587
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 16	-0.180408 milligram per deciliter (mg/dL) Standard Deviation 0.2254827	0.076326 milligram per deciliter (mg/dL) Standard Deviation 0.2138345	0.111020 milligram per deciliter (mg/dL) Standard Deviation 0.3376541
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Glucose, at Week 24	-0.249795 milligram per deciliter (mg/dL) Standard Deviation 0.3040408	-0.208163 milligram per deciliter (mg/dL) Standard Deviation 0.3557469	0.237900 milligram per deciliter (mg/dL) Standard Deviation 0.3184202
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Baseline	3.83775 milligram per deciliter (mg/dL) Standard Deviation 0.731134	4.19475 milligram per deciliter (mg/dL) Standard Deviation 1.376981	4.73025 milligram per deciliter (mg/dL) Standard Deviation 1.594955
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 2	1.21380 milligram per deciliter (mg/dL) Standard Deviation 0.678703	0.39270 milligram per deciliter (mg/dL) Standard Deviation 0.937762	0.27221 milligram per deciliter (mg/dL) Standard Deviation 1.307383
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Day 7	0.30345 milligram per deciliter (mg/dL) Standard Deviation 1.042747	0.58459 milligram per deciliter (mg/dL) Standard Deviation 1.250583	-0.42840 milligram per deciliter (mg/dL) Standard Deviation 1.421995
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	0.02678 milligram per deciliter (mg/dL) Standard Deviation 0.714446	-0.33915 milligram per deciliter (mg/dL) Standard Deviation 1.192768	-0.50873 milligram per deciliter (mg/dL) Standard Deviation 1.656633
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Week 4	0.31684 milligram per deciliter (mg/dL) Standard Deviation 0.895135	-0.16065 milligram per deciliter (mg/dL) Standard Deviation 0.695659	-0.24098 milligram per deciliter (mg/dL) Standard Deviation 1.082288
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Blood urea nitrogen, at Week 16	0.21420 milligram per deciliter (mg/dL) Standard Deviation 1.260309	-0.41948 milligram per deciliter (mg/dL) Standard Deviation 0.805711	0.03060 milligram per deciliter (mg/dL) Standard Deviation 1.359639
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Baseline	68.2890 milligram per deciliter (mg/dL) Standard Deviation 15.18504	68.0680 milligram per deciliter (mg/dL) Standard Deviation 13.56381	73.8140 milligram per deciliter (mg/dL) Standard Deviation 15.20157
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Day 2	1.4365 milligram per deciliter (mg/dL) Standard Deviation 8.05969	-3.2045 milligram per deciliter (mg/dL) Standard Deviation 3.97975	2.3205 milligram per deciliter (mg/dL) Standard Deviation 9.02667
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 7	0.0000 milligram per deciliter (mg/dL) Standard Deviation 5.84472	2.4310 milligram per deciliter (mg/dL) Standard Deviation 6.71158	6.2985 milligram per deciliter (mg/dL) Standard Deviation 9.30077
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	0.1105 milligram per deciliter (mg/dL) Standard Deviation 3.82236	0.6630 milligram per deciliter (mg/dL) Standard Deviation 6.49175	3.4255 milligram per deciliter (mg/dL) Standard Deviation 5.98510
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 4	2.9835 milligram per deciliter (mg/dL) Standard Deviation 7.05521	0.1105 milligram per deciliter (mg/dL) Standard Deviation 4.18485	2.7625 milligram per deciliter (mg/dL) Standard Deviation 6.78911
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 16	-0.3315 milligram per deciliter (mg/dL) Standard Deviation 6.87895	-0.7735 milligram per deciliter (mg/dL) Standard Deviation 7.98314	3.1571 milligram per deciliter (mg/dL) Standard Deviation 5.32501
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Creatinine, at Week 24	2.0995 milligram per deciliter (mg/dL) Standard Deviation 4.25102	-0.2210 milligram per deciliter (mg/dL) Standard Deviation 5.62574	5.6829 milligram per deciliter (mg/dL) Standard Deviation 7.60201
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Baseline	2.0306 milligram per deciliter (mg/dL) Standard Deviation 0.49592	1.7741 milligram per deciliter (mg/dL) Standard Deviation 0.62621	2.1161 milligram per deciliter (mg/dL) Standard Deviation 1.04191
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 2	-0.5771 milligram per deciliter (mg/dL) Standard Deviation 0.42811	-0.2138 milligram per deciliter (mg/dL) Standard Deviation 0.45473	-0.0214 milligram per deciliter (mg/dL) Standard Deviation 0.44250
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
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Day 7	0.0000 milligram per deciliter (mg/dL) Standard Deviation 0.43836	0.0214 milligram per deciliter (mg/dL) Standard Deviation 0.42320	-0.1283 milligram per deciliter (mg/dL) Standard Deviation 0.33893
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	-0.2351 milligram per deciliter (mg/dL) Standard Deviation 0.57763	-0.3634 milligram per deciliter (mg/dL) Standard Deviation 0.46997	-0.1710 milligram per deciliter (mg/dL) Standard Deviation 0.44778
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Direct Bilirubin, at Week 24	-0.3420 milligram per deciliter (mg/dL) Standard Deviation 0.49222	-0.2565 milligram per deciliter (mg/dL) Standard Deviation 0.61993	-0.3176 milligram per deciliter (mg/dL) Standard Deviation 0.36178
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Baseline	9.7684 milligram per deciliter (mg/dL) Standard Deviation 3.95623	10.4738 milligram per deciliter (mg/dL) Standard Deviation 3.28512	12.5258 milligram per deciliter (mg/dL) Standard Deviation 7.47987
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Day 2	-1.9879 milligram per deciliter (mg/dL) Standard Deviation 2.22382	-1.1115 milligram per deciliter (mg/dL) Standard Deviation 3.08613	0.6413 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 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	1.6031 milligram per deciliter (mg/dL) Standard Deviation 2.82603	-0.2565 milligram per deciliter (mg/dL) Standard Deviation 3.16102	-0.4703 milligram per deciliter (mg/dL) Standard Deviation 2.08181
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	0.6199 milligram per deciliter (mg/dL) Standard Deviation 3.02728	-2.4368 milligram per deciliter (mg/dL) Standard Deviation 2.07377	-0.6199 milligram per deciliter (mg/dL) Standard Deviation 3.52222
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 16	-0.4061 milligram per deciliter (mg/dL) Standard Deviation 3.45758	-1.5390 milligram per deciliter (mg/dL) Standard Deviation 2.90772	-2.4917 milligram per deciliter (mg/dL) Standard Deviation 2.46196
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin Total bilirubin, at Week 24	0.0428 milligram per deciliter (mg/dL) Standard Deviation 2.98813	-0.6840 milligram per deciliter (mg/dL) Standard Deviation 3.10368	-1.6856 milligram per deciliter (mg/dL) Standard Deviation 2.63700

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 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 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.
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Baseline	2.329706 Millimole per liter (mmol/L) Standard Deviation 0.1049575	2.317231 Millimole per liter (mmol/L) Standard Deviation 0.0805028	2.351538 Millimole per liter (mmol/L) Standard Deviation 0.0931159
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Day 2	-0.015594 Millimole per liter (mmol/L) Standard Deviation 0.1041067	-0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0983979	-0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0983979
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 Week 4	-0.031188 Millimole per liter (mmol/L) Standard Deviation 0.0739536	-0.034306 Millimole per liter (mmol/L) Standard Deviation 0.0853291	0.003119 Millimole per liter (mmol/L) Standard Deviation 0.0826826
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Week 24	-0.056138 Millimole per liter (mmol/L) Standard Deviation 0.0861717	-0.031188 Millimole per liter (mmol/L) Standard Deviation 0.0371268	-0.053464 Millimole per liter (mmol/L) Standard Deviation 0.1002445
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Baseline	29.4 Millimole per liter (mmol/L) Standard Deviation 1.77	27.8 Millimole per liter (mmol/L) Standard Deviation 2.25	28.6 Millimole per liter (mmol/L) Standard Deviation 1.92
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 1.39	0.3 Millimole per liter (mmol/L) Standard Deviation 1.28	0.3 Millimole per liter (mmol/L) Standard Deviation 0.71
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 Chloride, at Day 14	-1.6 Millimole per liter (mmol/L) Standard Deviation 1.77	1.0 Millimole per liter (mmol/L) Standard Deviation 2.56	0.4 Millimole per liter (mmol/L) Standard Deviation 2.13
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Baseline	4.36 Millimole per liter (mmol/L) Standard Deviation 0.484	4.14 Millimole per liter (mmol/L) Standard Deviation 0.342	4.29 Millimole per liter (mmol/L) Standard Deviation 0.485
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Baseline	138.8 Millimole per liter (mmol/L) Standard Deviation 1.39	137.1 Millimole per liter (mmol/L) Standard Deviation 2.23	136.9 Millimole per liter (mmol/L) Standard Deviation 2.53
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 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	-0.012475 Millimole per liter (mmol/L) Standard Deviation 0.0533453	-0.006238 Millimole per liter (mmol/L) Standard Deviation 0.0830180	0.037425 Millimole per liter (mmol/L) Standard Deviation 0.0442316
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	0.009356 Millimole per liter (mmol/L) Standard Deviation 0.0398698	-0.034306 Millimole per liter (mmol/L) Standard Deviation 0.0923367	-0.009356 Millimole per liter (mmol/L) Standard Deviation 0.0923367
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Calcium, at Week 16	-0.015594 Millimole per liter (mmol/L) Standard Deviation 0.0842805	0.018713 Millimole per liter (mmol/L) Standard Deviation 0.0751464	-0.064157 Millimole per liter (mmol/L) Standard Deviation 0.0496021
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Day 2	0.5 Millimole per liter (mmol/L) Standard Deviation 1.41	0.6 Millimole per liter (mmol/L) Standard Deviation 1.19	0.4 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 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	0.3 Millimole per liter (mmol/L) Standard Deviation 0.89	0.5 Millimole per liter (mmol/L) Standard Deviation 1.51	-0.4 Millimole per liter (mmol/L) Standard Deviation 1.41
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 4	1.5 Millimole per liter (mmol/L) Standard Deviation 1.51	0.9 Millimole per liter (mmol/L) Standard Deviation 1.64	0.0 Millimole per liter (mmol/L) Standard Deviation 0.93
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 16	-1.3 Millimole per liter (mmol/L) Standard Deviation 1.28	0.3 Millimole per liter (mmol/L) Standard Deviation 0.71	-0.4 Millimole per liter (mmol/L) Standard Deviation 0.98
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Carbon Dioxide, at Week 24	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.20	0.4 Millimole per liter (mmol/L) Standard Deviation 1.51	0.3 Millimole per liter (mmol/L) Standard Deviation 1.38
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Baseline	103.1 Millimole per liter (mmol/L) Standard Deviation 1.81	102.1 Millimole per liter (mmol/L) Standard Deviation 2.59	102.4 Millimole per liter (mmol/L) Standard Deviation 2.20
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Day 2	-0.6 Millimole per liter (mmol/L) Standard Deviation 2.45	0.0 Millimole per liter (mmol/L) Standard Deviation 2.00	0.1 Millimole per liter (mmol/L) Standard Deviation 2.42
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 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	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.07	0.1 Millimole per liter (mmol/L) Standard Deviation 1.64	0.5 Millimole per liter (mmol/L) Standard Deviation 2.14
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 Week 4	-1.3 Millimole per liter (mmol/L) Standard Deviation 2.38	1.1 Millimole per liter (mmol/L) Standard Deviation 2.47	0.4 Millimole per liter (mmol/L) Standard Deviation 1.06
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Week 16	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.13	1.5 Millimole per liter (mmol/L) Standard Deviation 1.41	0.7 Millimole per liter (mmol/L) Standard Deviation 1.80
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Chloride, at Week 24	-0.1 Millimole per liter (mmol/L) Standard Deviation 2.36	0.6 Millimole per liter (mmol/L) Standard Deviation 2.26	1.7 Millimole per liter (mmol/L) Standard Deviation 2.21
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Day 2	0.09 Millimole per liter (mmol/L) Standard Deviation 0.242	0.16 Millimole per liter (mmol/L) Standard Deviation 0.325	0.10 Millimole per liter (mmol/L) Standard Deviation 0.366
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	-0.30 Millimole per liter (mmol/L) Standard Deviation 0.421	0.29 Millimole per liter (mmol/L) Standard Deviation 0.470	-0.01 Millimole per liter (mmol/L) Standard Deviation 0.340
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	-0.13 Millimole per liter (mmol/L) Standard Deviation 0.381	0.04 Millimole per liter (mmol/L) Standard Deviation 0.513	0.09 Millimole per liter (mmol/L) Standard Deviation 0.458
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 4	-0.16 Millimole per liter (mmol/L) Standard Deviation 0.389	0.18 Millimole per liter (mmol/L) Standard Deviation 0.183	-0.01 Millimole per liter (mmol/L) Standard Deviation 0.196
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 16	-0.38 Millimole per liter (mmol/L) Standard Deviation 0.413	0.11 Millimole per liter (mmol/L) Standard Deviation 0.189	-0.04 Millimole per liter (mmol/L) Standard Deviation 0.382
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Potassium, at Week 24	-0.06 Millimole per liter (mmol/L) Standard Deviation 0.245	-0.03 Millimole per liter (mmol/L) Standard Deviation 0.354	0.01 Millimole per liter (mmol/L) Standard Deviation 0.308
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Day 2	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.13	-0.4 Millimole per liter (mmol/L) Standard Deviation 2.26	0.1 Millimole per liter (mmol/L) Standard Deviation 2.30
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 7	-0.5 Millimole per liter (mmol/L) Standard Deviation 1.77	0.5 Millimole per liter (mmol/L) Standard Deviation 2.20	0.8 Millimole per liter (mmol/L) Standard Deviation 1.98
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	-1.3 Millimole per liter (mmol/L) Standard Deviation 1.39	1.0 Millimole per liter (mmol/L) Standard Deviation 2.88	0.6 Millimole per liter (mmol/L) Standard Deviation 1.85
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 4	-0.9 Millimole per liter (mmol/L) Standard Deviation 2.17	1.0 Millimole per liter (mmol/L) Standard Deviation 2.45	0.9 Millimole per liter (mmol/L) Standard Deviation 1.64
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 16	-0.8 Millimole per liter (mmol/L) Standard Deviation 1.58	1.0 Millimole per liter (mmol/L) Standard Deviation 2.51	1.3 Millimole per liter (mmol/L) Standard Deviation 1.60
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide Sodium, at Week 24	-1.1 Millimole per liter (mmol/L) Standard Deviation 2.53	0.1 Millimole per liter (mmol/L) Standard Deviation 3.48	2.0 Millimole per liter (mmol/L) Standard Deviation 2.24

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 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 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.
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) ALP, at Week 16	4.8 International Units per liter (IU/L) Standard Deviation 5.23	5.4 International Units per liter (IU/L) Standard Deviation 5.42	1.0 International Units per liter (IU/L) Standard Deviation 5.39
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Baseline	11.8 International Units per liter (IU/L) Standard Deviation 2.71	12.5 International Units per liter (IU/L) Standard Deviation 4.00	20.0 International Units per liter (IU/L) Standard Deviation 8.09
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Day 2	0.6 International Units per liter (IU/L) Standard Deviation 1.69	-0.5 International Units per liter (IU/L) Standard Deviation 1.31	-1.8 International Units per liter (IU/L) Standard Deviation 3.45
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	1.5 International Units per liter (IU/L) Standard Deviation 2.83	0.5 International Units per liter (IU/L) Standard Deviation 2.73	2.0 International Units per liter (IU/L) Standard Deviation 7.91
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	1.0 International Units per liter (IU/L) Standard Deviation 1.41	0.6 International Units per liter (IU/L) Standard Deviation 2.13	-2.0 International Units per liter (IU/L) Standard Deviation 5.81
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 4	4.3 International Units per liter (IU/L) Standard Deviation 6.34	1.6 International Units per liter (IU/L) Standard Deviation 3.66	-1.9 International Units per liter (IU/L) Standard Deviation 8.18
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 16	4.4 International Units per liter (IU/L) Standard Deviation 2.72	1.4 International Units per liter (IU/L) Standard Deviation 2.45	-0.1 International Units per liter (IU/L) Standard Deviation 7.06
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALT, at Week 24	2.0 International Units per liter (IU/L) Standard Deviation 4.44	1.3 International Units per liter (IU/L) Standard Deviation 5.70	-1.3 International Units per liter (IU/L) Standard Deviation 5.96
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Baseline	14.5 International Units per liter (IU/L) Standard Deviation 2.39	16.0 International Units per liter (IU/L) Standard Deviation 2.98	18.1 International Units per liter (IU/L) Standard Deviation 2.64
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Day 2	0.4 International Units per liter (IU/L) Standard Deviation 2.00	1.4 International Units per liter (IU/L) Standard Deviation 1.77	-1.8 International Units per liter (IU/L) Standard Deviation 3.06
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	2.8 International Units per liter (IU/L) Standard Deviation 2.82	0.8 International Units per liter (IU/L) Standard Deviation 3.06	2.5 International Units per liter (IU/L) Standard Deviation 3.74
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	1.9 International Units per liter (IU/L) Standard Deviation 2.03	1.8 International Units per liter (IU/L) Standard Deviation 2.76	-0.9 International Units per liter (IU/L) Standard Deviation 3.40
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 4	3.0 International Units per liter (IU/L) Standard Deviation 3.51	4.3 International Units per liter (IU/L) Standard Deviation 8.96	0.0 International Units per liter (IU/L) Standard Deviation 4.38
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 16	2.9 International Units per liter (IU/L) Standard Deviation 1.81	1.1 International Units per liter (IU/L) Standard Deviation 3.14	0.4 International Units per liter (IU/L) Standard Deviation 3.95
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) AST, at Week 24	2.0 International Units per liter (IU/L) Standard Deviation 4.78	0.1 International Units per liter (IU/L) Standard Deviation 2.47	-0.7 International Units per liter (IU/L) Standard Deviation 2.63
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Baseline	54.6 International Units per liter (IU/L) Standard Deviation 8.99	55.9 International Units per liter (IU/L) Standard Deviation 20.00	57.1 International Units per liter (IU/L) Standard Deviation 9.30
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 2	2.9 International Units per liter (IU/L) Standard Deviation 3.83	0.6 International Units per liter (IU/L) Standard Deviation 4.50	-2.4 International Units per liter (IU/L) Standard Deviation 4.44
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	4.6 International Units per liter (IU/L) Standard Deviation 2.77	5.9 International Units per liter (IU/L) Standard Deviation 4.05	4.9 International Units per liter (IU/L) Standard Deviation 5.33
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	—
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Day 14	7.6 International Units per liter (IU/L) Standard Deviation 2.97	4.4 International Units per liter (IU/L) Standard Deviation 4.17	2.8 International Units per liter (IU/L) Standard Deviation 4.71
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Week 4	0.6 International Units per liter (IU/L) Standard Deviation 6.50	7.9 International Units per liter (IU/L) Standard Deviation 4.52	-1.8 International Units per liter (IU/L) Standard Deviation 2.76
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) ALP, at Week 24	-0.1 International Units per liter (IU/L) Standard Deviation 5.17	3.3 International Units per liter (IU/L) Standard Deviation 5.85	1.6 International Units per liter (IU/L) Standard Deviation 4.89

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 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 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.
Change From Baseline in Pulse Rate Baseline	73.9 Beats per minute (Beats/min) Standard Deviation 7.85	71.1 Beats per minute (Beats/min) Standard Deviation 7.16	75.9 Beats per minute (Beats/min) Standard Deviation 12.26
Change From Baseline in Pulse Rate Day 2	-4.4 Beats per minute (Beats/min) Standard Deviation 6.74	-7.6 Beats per minute (Beats/min) Standard Deviation 8.28	-13.8 Beats per minute (Beats/min) Standard Deviation 10.66
Change From Baseline in Pulse Rate Day 3	-7.6 Beats per minute (Beats/min) Standard Deviation 4.84	-5.4 Beats per minute (Beats/min) Standard Deviation 9.01	-12.1 Beats per minute (Beats/min) Standard Deviation 8.63
Change From Baseline in Pulse Rate Day 4	-6.4 Beats per minute (Beats/min) Standard Deviation 7.76	-4.3 Beats per minute (Beats/min) Standard Deviation 8.75	-8.1 Beats per minute (Beats/min) Standard Deviation 11.52
Change From Baseline in Pulse Rate Day 7	-1.4 Beats per minute (Beats/min) Standard Deviation 18.68	-9.4 Beats per minute (Beats/min) Standard Deviation 6.95	-8.4 Beats per minute (Beats/min) Standard Deviation 14.81
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	-4.5 Beats per minute (Beats/min) Standard Deviation 7.60	-10.0 Beats per minute (Beats/min) Standard Deviation 6.72	-11.4 Beats per minute (Beats/min) Standard Deviation 16.95
Change From Baseline in Pulse Rate Day 21	-3.1 Beats per minute (Beats/min) Standard Deviation 11.43	-9.1 Beats per minute (Beats/min) Standard Deviation 5.06	-11.0 Beats per minute (Beats/min) Standard Deviation 18.45
Change From Baseline in Pulse Rate Week 4	-7.3 Beats per minute (Beats/min) Standard Deviation 3.28	-9.9 Beats per minute (Beats/min) Standard Deviation 7.34	-13.4 Beats per minute (Beats/min) Standard Deviation 12.05
Change From Baseline in Pulse Rate Week 8	-3.9 Beats per minute (Beats/min) Standard Deviation 15.13	-8.0 Beats per minute (Beats/min) Standard Deviation 8.09	-8.3 Beats per minute (Beats/min) Standard Deviation 15.75
Change From Baseline in Pulse Rate Week 12	-4.8 Beats per minute (Beats/min) Standard Deviation 10.44	-6.3 Beats per minute (Beats/min) Standard Deviation 7.44	-9.8 Beats per minute (Beats/min) Standard Deviation 14.21
Change From Baseline in Pulse Rate Week 16	-11.1 Beats per minute (Beats/min) Standard Deviation 10.25	-5.1 Beats per minute (Beats/min) Standard Deviation 8.61	-10.6 Beats per minute (Beats/min) Standard Deviation 10.66
Change From Baseline in Pulse Rate Week 20	-9.0 Beats per minute (Beats/min) Standard Deviation 8.14	-5.0 Beats per minute (Beats/min) Standard Deviation 5.01	-12.4 Beats per minute (Beats/min) Standard Deviation 8.06
Change From Baseline in Pulse Rate Week 24	-10.5 Beats per minute (Beats/min) Standard Deviation 6.57	-4.3 Beats per minute (Beats/min) Standard Deviation 4.80	-15.3 Beats per minute (Beats/min) Standard Deviation 11.50

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 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 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.
Change From Baseline in Respiratory Rate Week 24	-3.3 Breaths per minute (Breaths/min) Standard Deviation 2.38	-2.5 Breaths per minute (Breaths/min) Standard Deviation 1.77	0.3 Breaths per minute (Breaths/min) Standard Deviation 2.93
Change From Baseline in Respiratory Rate Baseline	15.5 Breaths per minute (Breaths/min) Standard Deviation 1.41	15.8 Breaths per minute (Breaths/min) Standard Deviation 3.77	13.8 Breaths per minute (Breaths/min) Standard Deviation 1.98
Change From Baseline in Respiratory Rate Day 1/4 Hours Postdose	-1.4 Breaths per minute (Breaths/min) Standard Deviation 1.90	-0.3 Breaths per minute (Breaths/min) Standard Deviation 3.45	2.0 Breaths per minute (Breaths/min) Standard Deviation 3.38
Change From Baseline in Respiratory Rate Day 1/8 Hours Postdose	1.5 Breaths per minute (Breaths/min) Standard Deviation 2.56	-2.3 Breaths per minute (Breaths/min) Standard Deviation 2.25	0.8 Breaths per minute (Breaths/min) Standard Deviation 3.85
Change From Baseline in Respiratory Rate Day 2	-1.3 Breaths per minute (Breaths/min) Standard Deviation 3.20	-2.0 Breaths per minute (Breaths/min) Standard Deviation 3.85	1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12
Change From Baseline in Respiratory Rate Day 3	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12	-1.5 Breaths per minute (Breaths/min) Standard Deviation 4.24	2.3 Breaths per minute (Breaths/min) Standard Deviation 2.71
Change From Baseline in Respiratory Rate Day 4	-2.0 Breaths per minute (Breaths/min) Standard Deviation 2.14	-1.5 Breaths per minute (Breaths/min) Standard Deviation 3.16	0.0 Breaths per minute (Breaths/min) Standard Deviation 2.62
Change From Baseline in Respiratory Rate Day 7	0.8 Breaths per minute (Breaths/min) Standard Deviation 4.77	-2.8 Breaths per minute (Breaths/min) Standard Deviation 4.89	-0.3 Breaths per minute (Breaths/min) Standard Deviation 2.92
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	-1.5 Breaths per minute (Breaths/min) Standard Deviation 2.98	-2.0 Breaths per minute (Breaths/min) Standard Deviation 3.38	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.12
Change From Baseline in Respiratory Rate Day 21	-1.3 Breaths per minute (Breaths/min) Standard Deviation 2.60	-2.3 Breaths per minute (Breaths/min) Standard Deviation 2.92	1.0 Breaths per minute (Breaths/min) Standard Deviation 3.85
Change From Baseline in Respiratory Rate Week 4	1.3 Breaths per minute (Breaths/min) Standard Deviation 2.38	-2.0 Breaths per minute (Breaths/min) Standard Deviation 4.41	1.0 Breaths per minute (Breaths/min) Standard Deviation 2.83
Change From Baseline in Respiratory Rate Week 8	1.0 Breaths per minute (Breaths/min) Standard Deviation 2.83	-2.3 Breaths per minute (Breaths/min) Standard Deviation 4.59	1.3 Breaths per minute (Breaths/min) Standard Deviation 1.83
Change From Baseline in Respiratory Rate Week 12	-1.0 Breaths per minute (Breaths/min) Standard Deviation 2.14	-2.5 Breaths per minute (Breaths/min) Standard Deviation 3.34	1.5 Breaths per minute (Breaths/min) Standard Deviation 2.33
Change From Baseline in Respiratory Rate Week 16	-2.0 Breaths per minute (Breaths/min) Standard Deviation 4.28	-2.5 Breaths per minute (Breaths/min) Standard Deviation 5.42	3.1 Breaths per minute (Breaths/min) Standard Deviation 1.95
Change From Baseline in Respiratory Rate Week 20	-0.9 Breaths per minute (Breaths/min) Standard Deviation 3.80	-1.0 Breaths per minute (Breaths/min) Standard Deviation 3.21	1.1 Breaths per minute (Breaths/min) Standard Deviation 3.98

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 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 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.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 4	0.6 Millimeters of mercury (mmHg) Standard Deviation 6.05	-2.3 Millimeters of mercury (mmHg) Standard Deviation 4.62	-0.8 Millimeters of mercury (mmHg) Standard Deviation 4.86
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 7	1.9 Millimeters of mercury (mmHg) Standard Deviation 8.32	-1.6 Millimeters of mercury (mmHg) Standard Deviation 4.41	9.5 Millimeters of mercury (mmHg) Standard Deviation 9.78
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Baseline	112.8 Millimeters of mercury (mmHg) Standard Deviation 12.67	106.3 Millimeters of mercury (mmHg) Standard Deviation 11.68	114.4 Millimeters of mercury (mmHg) Standard Deviation 9.50
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 2	-4.1 Millimeters of mercury (mmHg) Standard Deviation 12.24	3.5 Millimeters of mercury (mmHg) Standard Deviation 8.04	-4.5 Millimeters of mercury (mmHg) Standard Deviation 7.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 3	-2.9 Millimeters of mercury (mmHg) Standard Deviation 7.49	0.8 Millimeters of mercury (mmHg) Standard Deviation 5.99	-4.5 Millimeters of mercury (mmHg) Standard Deviation 4.66
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 4	-0.5 Millimeters of mercury (mmHg) Standard Deviation 9.20	0.3 Millimeters of mercury (mmHg) Standard Deviation 6.45	-5.6 Millimeters of mercury (mmHg) Standard Deviation 6.23
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 8.18	2.1 Millimeters of mercury (mmHg) Standard Deviation 6.03	3.6 Millimeters of mercury (mmHg) Standard Deviation 8.28
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	2.4 Millimeters of mercury (mmHg) Standard Deviation 8.68	11.3 Millimeters of mercury (mmHg) Standard Deviation 9.19	6.5 Millimeters of mercury (mmHg) Standard Deviation 10.38
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Day 21	5.4 Millimeters of mercury (mmHg) Standard Deviation 10.21	9.8 Millimeters of mercury (mmHg) Standard Deviation 13.36	7.8 Millimeters of mercury (mmHg) Standard Deviation 11.50
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 4	-0.9 Millimeters of mercury (mmHg) Standard Deviation 8.54	9.5 Millimeters of mercury (mmHg) Standard Deviation 11.80	2.8 Millimeters of mercury (mmHg) Standard Deviation 7.85
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 8	9.0 Millimeters of mercury (mmHg) Standard Deviation 17.02	9.5 Millimeters of mercury (mmHg) Standard Deviation 14.43	5.6 Millimeters of mercury (mmHg) Standard Deviation 7.58
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 12	-3.8 Millimeters of mercury (mmHg) Standard Deviation 4.89	4.5 Millimeters of mercury (mmHg) Standard Deviation 16.38	7.9 Millimeters of mercury (mmHg) Standard Deviation 11.54
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 16	4.6 Millimeters of mercury (mmHg) Standard Deviation 5.55	7.9 Millimeters of mercury (mmHg) Standard Deviation 11.08	-0.3 Millimeters of mercury (mmHg) Standard Deviation 10.27
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 14.28	2.1 Millimeters of mercury (mmHg) Standard Deviation 10.83	6.3 Millimeters of mercury (mmHg) Standard Deviation 7.83
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Systolic Blood Pressure, at Week 24	2.0 Millimeters of mercury (mmHg) Standard Deviation 7.78	6.4 Millimeters of mercury (mmHg) Standard Deviation 10.07	-0.1 Millimeters of mercury (mmHg) Standard Deviation 4.91
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Baseline	66.5 Millimeters of mercury (mmHg) Standard Deviation 9.71	59.8 Millimeters of mercury (mmHg) Standard Deviation 6.45	62.1 Millimeters of mercury (mmHg) Standard Deviation 5.59
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 2	-1.6 Millimeters of mercury (mmHg) Standard Deviation 5.48	3.4 Millimeters of mercury (mmHg) Standard Deviation 8.23	-0.5 Millimeters of mercury (mmHg) Standard Deviation 6.89
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 3	2.4 Millimeters of mercury (mmHg) Standard Deviation 4.87	1.1 Millimeters of mercury (mmHg) Standard Deviation 7.24	-1.9 Millimeters of mercury (mmHg) Standard Deviation 5.51
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	1.6 Millimeters of mercury (mmHg) Standard Deviation 6.63	6.1 Millimeters of mercury (mmHg) Standard Deviation 3.72	6.1 Millimeters of mercury (mmHg) Standard Deviation 5.33
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Day 21	2.8 Millimeters of mercury (mmHg) Standard Deviation 6.50	10.6 Millimeters of mercury (mmHg) Standard Deviation 8.37	12.9 Millimeters of mercury (mmHg) Standard Deviation 4.67
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 4	2.1 Millimeters of mercury (mmHg) Standard Deviation 7.24	8.1 Millimeters of mercury (mmHg) Standard Deviation 6.40	7.6 Millimeters of mercury (mmHg) Standard Deviation 6.32
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 8	6.4 Millimeters of mercury (mmHg) Standard Deviation 7.74	9.1 Millimeters of mercury (mmHg) Standard Deviation 3.44	7.6 Millimeters of mercury (mmHg) Standard Deviation 3.29
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 12	0.5 Millimeters of mercury (mmHg) Standard Deviation 4.96	6.8 Millimeters of mercury (mmHg) Standard Deviation 7.15	11.5 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 Week 16	3.8 Millimeters of mercury (mmHg) Standard Deviation 3.15	9.1 Millimeters of mercury (mmHg) Standard Deviation 5.11	8.4 Millimeters of mercury (mmHg) Standard Deviation 6.73
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 20	-2.0 Millimeters of mercury (mmHg) Standard Deviation 7.09	6.3 Millimeters of mercury (mmHg) Standard Deviation 5.55	13.6 Millimeters of mercury (mmHg) Standard Deviation 6.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Diastolic Blood Pressure, at Week 24	1.5 Millimeters of mercury (mmHg) Standard Deviation 4.28	7.4 Millimeters of mercury (mmHg) Standard Deviation 6.57	12.1 Millimeters of mercury (mmHg) Standard Deviation 7.49

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.