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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

A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05291520
Acronym
SPAN
Enrollment
24
Registered
2022-03-22
Start date
2022-02-23
Completion date
2023-04-10
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

VH3810109, GSK3810109, HIV, Human Monoclonal Antibody, rHuPH20, Pharmacokinetics, Safety, Tolerability, N6LS

Brief summary

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

Interventions

BIOLOGICALVH3810109

VH3810109 was administered.

BIOLOGICALrHuPH20

rHuPH20 was administered.

Sponsors

ViiV Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This will be an open-label study. Hence, there will be no masking.

Intervention model description

Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the

Exclusion criteria

. * Participants having body weight of ≥50 kilogram (kg) and \<100 kg * Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening. * Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not pregnant or breastfeeding and at least one of the following conditions applies: Is not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the start of this study and during the study. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the first dose of study intervention All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom). The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy. * Capable of giving written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)Up to Week 24An 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.
Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)Up to Week 24An 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.
Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)Up to 7 days post-doseISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)Up to Week 24Liver 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.
Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)Up to Week 24An 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.
Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)Up to Week 24An 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.
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)Up to Week 24Liver 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.

Secondary

MeasureTime frameDescription
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)At Day 2 and Day 7The 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.
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)At Day 2 and Day 7The 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.
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)At Day 1, Day 2 and Day 7Post-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).
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)At Day 1, Day 2 and Day 7Post-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).
Number of ISRs Events Overall and by Grade (Part 1 and 3)Up to day 14ISRs 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.
The Overall Duration of ISRs, Expressed in DaysFrom Day 1 up to Day 14ISRs will be recorded via ISR diaries and managed through investigator assessment.
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsFrom Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Change From Baseline in HematocritFrom Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Change From Baseline in Hemoglobin, Albumin and Total ProteinFrom Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Change From Baseline in Red Blood Cell Count (RBC)From Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109Up to Week 24Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)From Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinFrom Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideFrom Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineDay 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.
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)From Baseline (Day -1) up to Week 24ECG values were collected as assessed by protocol, at the indicated time points.
Change From Baseline in TemperatureFrom Baseline (Day -1) up to Week 24Temperature 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.
Change From Baseline in Pulse RateFrom Baseline (Day -1) up to Week 24Pulse 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.
Change From Baseline in Respiratory RateFrom Baseline (Day -1) up to Week 24Respiratory 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.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)From Baseline (Day -1) up to Week 24Blood 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.
Change From Baseline in Mean Corpuscle Volume (MCV)From Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
AUC From Time Zero to Time t (AUC[0-t]) of VH3810109Up to Week 24Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Maximum Observed Concentration (Cmax) of VH3810109Up to Week 24Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Time of Maximum Observed Concentration (Tmax) of VH3810109Up to Week 24Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Apparent Terminal Phase Half-life (t1/2) of VH3810109Up to Week 24Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)At Day 2 and Day 7The 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.
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)From Baseline (Day -1) up to Week 24Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
8
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.
8
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.
8
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up001

Baseline characteristics

CharacteristicPart 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Part 2 Group: VH3810109 60 mg/kg [IV]Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Total
Age, Continuous42.8 Years
STANDARD_DEVIATION 7.76
40.0 Years
STANDARD_DEVIATION 14.45
39.9 Years
STANDARD_DEVIATION 10.59
40.87 Years
STANDARD_DEVIATION 10.85
Race/Ethnicity, Customized
Asian
2 Participants1 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants2 Participants4 Participants7 Participants
Race/Ethnicity, Customized
Multiple
0 Participants1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White
5 Participants4 Participants3 Participants12 Participants
Sex: Female, Male
Female
5 Participants7 Participants3 Participants15 Participants
Sex: Female, Male
Male
3 Participants1 Participants5 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 80 / 8
other
Total, other adverse events
8 / 81 / 88 / 8
serious
Total, serious adverse events
0 / 80 / 80 / 8

Outcome results

Primary

Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)0 Participants
Primary

Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)7 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)8 Participants
Primary

Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 30 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 40 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 30 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 40 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 30 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 40 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 30 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 40 Participants
Primary

Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)ALT, Grade 30 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)ALT, Grade 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)ALT, Grade 40 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)AST, Grade 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)AST, Grade 30 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)AST, Grade 40 Participants
Primary

Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)

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

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)7 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)8 Participants
Primary

Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)0 Participants
Primary

Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)0 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)0 Participants
Secondary

Apparent Terminal Phase Half-life (t1/2) of VH3810109

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

Time frame: 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.

ArmMeasureValue (MEAN)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Apparent Terminal Phase Half-life (t1/2) of VH381010938.17 Days
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Apparent Terminal Phase Half-life (t1/2) of VH381010946.97 Days
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Apparent Terminal Phase Half-life (t1/2) of VH381010944.95 Days
Secondary

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109

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

Time frame: 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.

ArmMeasureValue (MEAN)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH38101097587 Day*microgram/mililitre (day*μg/mL)
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH381010931560 Day*microgram/mililitre (day*μg/mL)
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH381010912840 Day*microgram/mililitre (day*μg/mL)
Secondary

AUC From Time Zero to Time t (AUC[0-t]) of VH3810109

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

Time frame: 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.

ArmMeasureValue (MEAN)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]AUC From Time Zero to Time t (AUC[0-t]) of VH38101096996 day*μg/mL
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]AUC From Time Zero to Time t (AUC[0-t]) of VH381010929160 day*μg/mL
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]AUC From Time Zero to Time t (AUC[0-t]) of VH381010911590 day*μg/mL
Secondary

Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 141.0 International Units per liter (IU/L)Standard Deviation 1.41
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 22.9 International Units per liter (IU/L)Standard Deviation 3.83
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 162.9 International Units per liter (IU/L)Standard Deviation 1.81
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 44.3 International Units per liter (IU/L)Standard Deviation 6.34
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 164.8 International Units per liter (IU/L)Standard Deviation 5.23
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 43.0 International Units per liter (IU/L)Standard Deviation 3.51
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 164.4 International Units per liter (IU/L)Standard Deviation 2.72
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Baseline11.8 International Units per liter (IU/L)Standard Deviation 2.71
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 141.9 International Units per liter (IU/L)Standard Deviation 2.03
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 242.0 International Units per liter (IU/L)Standard Deviation 4.44
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 40.6 International Units per liter (IU/L)Standard Deviation 6.5
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 72.8 International Units per liter (IU/L)Standard Deviation 2.82
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Baseline14.5 International Units per liter (IU/L)Standard Deviation 2.39
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 147.6 International Units per liter (IU/L)Standard Deviation 2.97
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 20.4 International Units per liter (IU/L)Standard Deviation 2
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 74.6 International Units per liter (IU/L)Standard Deviation 2.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 71.5 International Units per liter (IU/L)Standard Deviation 2.83
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Baseline54.6 International Units per liter (IU/L)Standard Deviation 8.99
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 20.6 International Units per liter (IU/L)Standard Deviation 1.69
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 242.0 International Units per liter (IU/L)Standard Deviation 4.78
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 20.6 International Units per liter (IU/L)Standard Deviation 4.5
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 144.4 International Units per liter (IU/L)Standard Deviation 4.17
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Baseline12.5 International Units per liter (IU/L)Standard Deviation 4
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 2-0.5 International Units per liter (IU/L)Standard Deviation 1.31
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 30.5 International Units per liter (IU/L)Standard Deviation 1.52
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 40.5 International Units per liter (IU/L)Standard Deviation 2.43
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 70.5 International Units per liter (IU/L)Standard Deviation 2.73
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 80.8 International Units per liter (IU/L)Standard Deviation 3.76
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 140.6 International Units per liter (IU/L)Standard Deviation 2.13
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 41.6 International Units per liter (IU/L)Standard Deviation 3.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 161.4 International Units per liter (IU/L)Standard Deviation 2.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 241.3 International Units per liter (IU/L)Standard Deviation 5.7
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Baseline16.0 International Units per liter (IU/L)Standard Deviation 2.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 21.4 International Units per liter (IU/L)Standard Deviation 1.77
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 32.7 International Units per liter (IU/L)Standard Deviation 1.63
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 41.8 International Units per liter (IU/L)Standard Deviation 1.72
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 70.8 International Units per liter (IU/L)Standard Deviation 3.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 81.0 International Units per liter (IU/L)Standard Deviation 3.03
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 141.8 International Units per liter (IU/L)Standard Deviation 2.76
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 44.3 International Units per liter (IU/L)Standard Deviation 8.96
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 161.1 International Units per liter (IU/L)Standard Deviation 3.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 240.1 International Units per liter (IU/L)Standard Deviation 2.47
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Baseline55.9 International Units per liter (IU/L)Standard Deviation 20
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 34.7 International Units per liter (IU/L)Standard Deviation 4.03
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 44.0 International Units per liter (IU/L)Standard Deviation 5.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 75.9 International Units per liter (IU/L)Standard Deviation 4.05
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 86.8 International Units per liter (IU/L)Standard Deviation 5.04
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 47.9 International Units per liter (IU/L)Standard Deviation 4.52
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 165.4 International Units per liter (IU/L)Standard Deviation 5.42
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 243.3 International Units per liter (IU/L)Standard Deviation 5.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 14-2.0 International Units per liter (IU/L)Standard Deviation 5.81
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 142.8 International Units per liter (IU/L)Standard Deviation 4.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 160.4 International Units per liter (IU/L)Standard Deviation 3.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Baseline57.1 International Units per liter (IU/L)Standard Deviation 9.3
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 3-1.1 International Units per liter (IU/L)Standard Deviation 4.61
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 24-0.7 International Units per liter (IU/L)Standard Deviation 2.63
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 72.0 International Units per liter (IU/L)Standard Deviation 7.91
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Baseline20.0 International Units per liter (IU/L)Standard Deviation 8.09
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 2-2.4 International Units per liter (IU/L)Standard Deviation 4.44
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Baseline18.1 International Units per liter (IU/L)Standard Deviation 2.64
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 4-1.8 International Units per liter (IU/L)Standard Deviation 2.76
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 2-1.8 International Units per liter (IU/L)Standard Deviation 3.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 30.0 International Units per liter (IU/L)Standard Deviation 4.81
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 3-0.6 International Units per liter (IU/L)Standard Deviation 3.42
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 2-1.8 International Units per liter (IU/L)Standard Deviation 3.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 40.5 International Units per liter (IU/L)Standard Deviation 3.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 24-1.3 International Units per liter (IU/L)Standard Deviation 5.96
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 43.0 International Units per liter (IU/L)Standard Deviation 3.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 72.5 International Units per liter (IU/L)Standard Deviation 3.74
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Day 4-0.8 International Units per liter (IU/L)Standard Deviation 6.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 241.6 International Units per liter (IU/L)Standard Deviation 4.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 16-0.1 International Units per liter (IU/L)Standard Deviation 7.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Day 74.9 International Units per liter (IU/L)Standard Deviation 5.33
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Day 14-0.9 International Units per liter (IU/L)Standard Deviation 3.4
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALT, at Week 4-1.9 International Units per liter (IU/L)Standard Deviation 8.18
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)ALP, at Week 161.0 International Units per liter (IU/L)Standard Deviation 5.39
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)AST, at Week 40.0 International Units per liter (IU/L)Standard Deviation 4.38
Secondary

Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Baseline5.009778 milligram per deciliter (mg/dL)Standard Deviation 0.2649736
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 2-0.006939 milligram per deciliter (mg/dL)Standard Deviation 0.2306696
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 70.180408 milligram per deciliter (mg/dL)Standard Deviation 0.1723749
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 14-0.027755 milligram per deciliter (mg/dL)Standard Deviation 0.2586688
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 40.027755 milligram per deciliter (mg/dL)Standard Deviation 0.3857275
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 16-0.180408 milligram per deciliter (mg/dL)Standard Deviation 0.2254827
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 140.02678 milligram per deciliter (mg/dL)Standard Deviation 0.714446
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 40.31684 milligram per deciliter (mg/dL)Standard Deviation 0.895135
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Baseline68.2890 milligram per deciliter (mg/dL)Standard Deviation 15.18504
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 21.4365 milligram per deciliter (mg/dL)Standard Deviation 8.05969
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 70.0000 milligram per deciliter (mg/dL)Standard Deviation 5.84472
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 140.1105 milligram per deciliter (mg/dL)Standard Deviation 3.82236
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 16-0.3315 milligram per deciliter (mg/dL)Standard Deviation 6.87895
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 242.0995 milligram per deciliter (mg/dL)Standard Deviation 4.25102
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Baseline2.0306 milligram per deciliter (mg/dL)Standard Deviation 0.49592
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 2-0.5771 milligram per deciliter (mg/dL)Standard Deviation 0.42811
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 14-0.2351 milligram per deciliter (mg/dL)Standard Deviation 0.57763
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 4-0.5344 milligram per deciliter (mg/dL)Standard Deviation 0.62287
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 16-0.3206 milligram per deciliter (mg/dL)Standard Deviation 0.59544
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 24-0.3420 milligram per deciliter (mg/dL)Standard Deviation 0.49222
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Baseline9.7684 milligram per deciliter (mg/dL)Standard Deviation 3.95623
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 2-1.9879 milligram per deciliter (mg/dL)Standard Deviation 2.22382
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 140.6199 milligram per deciliter (mg/dL)Standard Deviation 3.02728
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 4-1.7528 milligram per deciliter (mg/dL)Standard Deviation 3.77392
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 24-0.249795 milligram per deciliter (mg/dL)Standard Deviation 0.3040408
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Baseline3.83775 milligram per deciliter (mg/dL)Standard Deviation 0.731134
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 21.21380 milligram per deciliter (mg/dL)Standard Deviation 0.678703
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 70.30345 milligram per deciliter (mg/dL)Standard Deviation 1.042747
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 160.21420 milligram per deciliter (mg/dL)Standard Deviation 1.260309
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 240.32576 milligram per deciliter (mg/dL)Standard Deviation 1.074638
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 42.9835 milligram per deciliter (mg/dL)Standard Deviation 7.05521
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 70.0000 milligram per deciliter (mg/dL)Standard Deviation 0.43836
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 71.6031 milligram per deciliter (mg/dL)Standard Deviation 2.82603
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 16-0.4061 milligram per deciliter (mg/dL)Standard Deviation 3.45758
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 240.0428 milligram per deciliter (mg/dL)Standard Deviation 2.98813
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 40.0570 milligram per deciliter (mg/dL)Standard Deviation 2.84018
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 70.58459 milligram per deciliter (mg/dL)Standard Deviation 1.250583
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 24-0.2210 milligram per deciliter (mg/dL)Standard Deviation 5.62574
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 7-0.2565 milligram per deciliter (mg/dL)Standard Deviation 3.16102
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Baseline1.7741 milligram per deciliter (mg/dL)Standard Deviation 0.62621
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 16-0.41948 milligram per deciliter (mg/dL)Standard Deviation 0.805711
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 2-0.2138 milligram per deciliter (mg/dL)Standard Deviation 0.45473
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 3-0.1425 milligram per deciliter (mg/dL)Standard Deviation 0.45134
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 40.0285 milligram per deciliter (mg/dL)Standard Deviation 0.47656
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 70.0214 milligram per deciliter (mg/dL)Standard Deviation 0.4232
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 80.1995 milligram per deciliter (mg/dL)Standard Deviation 0.5344
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 10-0.5130 milligram per deciliter (mg/dL)Standard Deviation 0.48366
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 14-0.3634 milligram per deciliter (mg/dL)Standard Deviation 0.46997
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 40.0000 milligram per deciliter (mg/dL)Standard Deviation 0.42872
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 140.6630 milligram per deciliter (mg/dL)Standard Deviation 6.49175
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 16-0.2138 milligram per deciliter (mg/dL)Standard Deviation 0.52308
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 24-0.2565 milligram per deciliter (mg/dL)Standard Deviation 0.61993
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 80.9405 milligram per deciliter (mg/dL)Standard Deviation 3.54057
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Baseline10.4738 milligram per deciliter (mg/dL)Standard Deviation 3.28512
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 2-1.1115 milligram per deciliter (mg/dL)Standard Deviation 3.08613
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 10-2.3085 milligram per deciliter (mg/dL)Standard Deviation 1.81373
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 14-2.4368 milligram per deciliter (mg/dL)Standard Deviation 2.07377
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 3-0.8550 milligram per deciliter (mg/dL)Standard Deviation 2.99128
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 4-1.1115 milligram per deciliter (mg/dL)Standard Deviation 1.51851
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 24-0.6840 milligram per deciliter (mg/dL)Standard Deviation 3.10368
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 140.048571 milligram per deciliter (mg/dL)Standard Deviation 0.3884992
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 160.076326 milligram per deciliter (mg/dL)Standard Deviation 0.2138345
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 24-0.208163 milligram per deciliter (mg/dL)Standard Deviation 0.3557469
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Baseline5.037533 milligram per deciliter (mg/dL)Standard Deviation 0.258243
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 20.256734 milligram per deciliter (mg/dL)Standard Deviation 0.5881647
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 3-0.018503 milligram per deciliter (mg/dL)Standard Deviation 0.2930311
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 4-0.027755 milligram per deciliter (mg/dL)Standard Deviation 0.2868315
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 2-3.2045 milligram per deciliter (mg/dL)Standard Deviation 3.97975
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 70.548161 milligram per deciliter (mg/dL)Standard Deviation 1.1531574
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 8-0.111020 milligram per deciliter (mg/dL)Standard Deviation 0.33306
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 100.000000 milligram per deciliter (mg/dL)Standard Deviation 0.157006
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Baseline4.19475 milligram per deciliter (mg/dL)Standard Deviation 1.376981
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 4-0.124898 milligram per deciliter (mg/dL)Standard Deviation 0.2842106
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 80.55930 milligram per deciliter (mg/dL)Standard Deviation 0.8099
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 100.35700 milligram per deciliter (mg/dL)Standard Deviation 0
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 20.39270 milligram per deciliter (mg/dL)Standard Deviation 0.937762
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 14-0.33915 milligram per deciliter (mg/dL)Standard Deviation 1.192768
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 4-0.16065 milligram per deciliter (mg/dL)Standard Deviation 0.695659
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 240.26775 milligram per deciliter (mg/dL)Standard Deviation 1.47442
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 30.67830 milligram per deciliter (mg/dL)Standard Deviation 0.651268
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Baseline68.0680 milligram per deciliter (mg/dL)Standard Deviation 13.56381
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 3-0.7367 milligram per deciliter (mg/dL)Standard Deviation 6.16058
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 4-0.5893 milligram per deciliter (mg/dL)Standard Deviation 6.03887
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 40.82705 milligram per deciliter (mg/dL)Standard Deviation 0.92749
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 72.4310 milligram per deciliter (mg/dL)Standard Deviation 6.71158
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 8-0.4420 milligram per deciliter (mg/dL)Standard Deviation 6.0151
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 1011.9340 milligram per deciliter (mg/dL)Standard Deviation 3.12541
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 40.1105 milligram per deciliter (mg/dL)Standard Deviation 4.18485
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 16-1.5390 milligram per deciliter (mg/dL)Standard Deviation 2.90772
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 16-0.7735 milligram per deciliter (mg/dL)Standard Deviation 7.98314
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 22.3205 milligram per deciliter (mg/dL)Standard Deviation 9.02667
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 42.0306 milligram per deciliter (mg/dL)Standard Deviation 4.6485
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 33.6465 milligram per deciliter (mg/dL)Standard Deviation 5.49905
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 30.201224 milligram per deciliter (mg/dL)Standard Deviation 0.3645321
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 40.8840 milligram per deciliter (mg/dL)Standard Deviation 7.94898
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Baseline12.5258 milligram per deciliter (mg/dL)Standard Deviation 7.47987
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 16-2.4917 milligram per deciliter (mg/dL)Standard Deviation 2.46196
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 76.2985 milligram per deciliter (mg/dL)Standard Deviation 9.30077
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 7-0.42840 milligram per deciliter (mg/dL)Standard Deviation 1.421995
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 4-0.006939 milligram per deciliter (mg/dL)Standard Deviation 0.2852734
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 40.15619 milligram per deciliter (mg/dL)Standard Deviation 1.726718
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 20.6413 milligram per deciliter (mg/dL)Standard Deviation 2.98813
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 42.7625 milligram per deciliter (mg/dL)Standard Deviation 6.78911
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Baseline73.8140 milligram per deciliter (mg/dL)Standard Deviation 15.20157
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 14-0.6199 milligram per deciliter (mg/dL)Standard Deviation 3.52222
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 163.1571 milligram per deciliter (mg/dL)Standard Deviation 5.32501
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 4-0.24098 milligram per deciliter (mg/dL)Standard Deviation 1.082288
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 70.166530 milligram per deciliter (mg/dL)Standard Deviation 0.3408978
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Week 245.6829 milligram per deciliter (mg/dL)Standard Deviation 7.60201
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 4-0.3206 milligram per deciliter (mg/dL)Standard Deviation 3.67145
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 30.16511 milligram per deciliter (mg/dL)Standard Deviation 1.369415
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Baseline2.1161 milligram per deciliter (mg/dL)Standard Deviation 1.04191
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Week 24-1.6856 milligram per deciliter (mg/dL)Standard Deviation 2.637
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 24-0.05610 milligram per deciliter (mg/dL)Standard Deviation 1.187055
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 2-0.0214 milligram per deciliter (mg/dL)Standard Deviation 0.4425
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 140.006939 milligram per deciliter (mg/dL)Standard Deviation 0.2790329
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 3-0.1069 milligram per deciliter (mg/dL)Standard Deviation 0.43776
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 14-0.50873 milligram per deciliter (mg/dL)Standard Deviation 1.656633
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 40.1283 milligram per deciliter (mg/dL)Standard Deviation 0.58348
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 160.111020 milligram per deciliter (mg/dL)Standard Deviation 0.3376541
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 7-0.1283 milligram per deciliter (mg/dL)Standard Deviation 0.33893
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 30.4061 milligram per deciliter (mg/dL)Standard Deviation 3.48526
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Baseline4.73025 milligram per deciliter (mg/dL)Standard Deviation 1.594955
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Week 160.03060 milligram per deciliter (mg/dL)Standard Deviation 1.359639
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinBlood urea nitrogen, at Day 20.27221 milligram per deciliter (mg/dL)Standard Deviation 1.307383
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Day 14-0.1710 milligram per deciliter (mg/dL)Standard Deviation 0.44778
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinTotal bilirubin, at Day 7-0.4703 milligram per deciliter (mg/dL)Standard Deviation 2.08181
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Baseline4.864064 milligram per deciliter (mg/dL)Standard Deviation 0.2032812
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 4-0.1496 milligram per deciliter (mg/dL)Standard Deviation 0.50427
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 240.237900 milligram per deciliter (mg/dL)Standard Deviation 0.3184202
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Week 40.215101 milligram per deciliter (mg/dL)Standard Deviation 0.5168587
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 16-0.7817 milligram per deciliter (mg/dL)Standard Deviation 0.56591
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinCreatinine, at Day 143.4255 milligram per deciliter (mg/dL)Standard Deviation 5.9851
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinGlucose, at Day 20.145714 milligram per deciliter (mg/dL)Standard Deviation 0.2966207
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total BilirubinDirect Bilirubin, at Week 24-0.3176 milligram per deciliter (mg/dL)Standard Deviation 0.36178
Secondary

Change From Baseline in Hematocrit

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritDay 140.0118 Proportion of red blood cells in bloodStandard Deviation 0.01426
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritDay 70.0168 Proportion of red blood cells in bloodStandard Deviation 0.01662
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritBaseline0.3873 Proportion of red blood cells in bloodStandard Deviation 0.04541
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritWeek 40.0016 Proportion of red blood cells in bloodStandard Deviation 0.01672
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritWeek 240.0119 Proportion of red blood cells in bloodStandard Deviation 0.01389
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritWeek 160.0196 Proportion of red blood cells in bloodStandard Deviation 0.02303
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in HematocritDay 20.0159 Proportion of red blood cells in bloodStandard Deviation 0.02226
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 30.0100 Proportion of red blood cells in bloodStandard Deviation 0.02612
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 40.0003 Proportion of red blood cells in bloodStandard Deviation 0.01992
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 70.0043 Proportion of red blood cells in bloodStandard Deviation 0.01521
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 80.0062 Proportion of red blood cells in bloodStandard Deviation 0.01781
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 10-0.0270 Proportion of red blood cells in bloodStandard Deviation 0.01131
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 4-0.0013 Proportion of red blood cells in bloodStandard Deviation 0.01641
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 160.0078 Proportion of red blood cells in bloodStandard Deviation 0.02315
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritBaseline0.3928 Proportion of red blood cells in bloodStandard Deviation 0.04415
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 20.0005 Proportion of red blood cells in bloodStandard Deviation 0.01513
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 14-0.0074 Proportion of red blood cells in bloodStandard Deviation 0.01736
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 240.0053 Proportion of red blood cells in bloodStandard Deviation 0.02437
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 7-0.0065 Proportion of red blood cells in bloodStandard Deviation 0.01208
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 30.0066 Proportion of red blood cells in bloodStandard Deviation 0.01502
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 20.0118 Proportion of red blood cells in bloodStandard Deviation 0.01704
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 40.0023 Proportion of red blood cells in bloodStandard Deviation 0.01646
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 4-0.0069 Proportion of red blood cells in bloodStandard Deviation 0.01605
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 24-0.0076 Proportion of red blood cells in bloodStandard Deviation 0.03243
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritDay 14-0.0056 Proportion of red blood cells in bloodStandard Deviation 0.0142
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritWeek 16-0.0106 Proportion of red blood cells in bloodStandard Deviation 0.00759
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in HematocritBaseline0.4253 Proportion of red blood cells in bloodStandard Deviation 0.04709
Secondary

Change From Baseline in Hemoglobin, Albumin and Total Protein

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 20.4 Grams per liter (g/L)Standard Deviation 2.07
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 160.6 Grams per liter (g/L)Standard Deviation 1.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 164.3 Grams per liter (g/L)Standard Deviation 7.23
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 25.8 Grams per liter (g/L)Standard Deviation 6.9
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Baseline131.4 Grams per liter (g/L)Standard Deviation 16.78
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 140.0 Grams per liter (g/L)Standard Deviation 4.14
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 143.4 Grams per liter (g/L)Standard Deviation 4.78
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 24-3.4 Grams per liter (g/L)Standard Deviation 3.96
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 70.1 Grams per liter (g/L)Standard Deviation 2.8
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 24-1.5 Grams per liter (g/L)Standard Deviation 2.14
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 160.9 Grams per liter (g/L)Standard Deviation 2.42
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 4-1.4 Grams per liter (g/L)Standard Deviation 2.56
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 41.0 Grams per liter (g/L)Standard Deviation 5.29
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 4-0.6 Grams per liter (g/L)Standard Deviation 3.16
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 20.6 Grams per liter (g/L)Standard Deviation 4.17
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 70.0 Grams per liter (g/L)Standard Deviation 4.57
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 72.6 Grams per liter (g/L)Standard Deviation 6.35
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 140.0 Grams per liter (g/L)Standard Deviation 2
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 240.4 Grams per liter (g/L)Standard Deviation 4.07
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Baseline70.0 Grams per liter (g/L)Standard Deviation 3.85
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Baseline44.0 Grams per liter (g/L)Standard Deviation 3.02
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 83.3 Grams per liter (g/L)Standard Deviation 4.84
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 21.9 Grams per liter (g/L)Standard Deviation 4.61
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 36.8 Grams per liter (g/L)Standard Deviation 6.79
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 44.8 Grams per liter (g/L)Standard Deviation 7.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 72.9 Grams per liter (g/L)Standard Deviation 5.28
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 10-10.0 Grams per liter (g/L)Standard Deviation 4.24
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 14-0.8 Grams per liter (g/L)Standard Deviation 5.9
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 165.3 Grams per liter (g/L)Standard Deviation 8.01
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 244.0 Grams per liter (g/L)Standard Deviation 7.54
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 2-2.4 Grams per liter (g/L)Standard Deviation 2.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 3-0.3 Grams per liter (g/L)Standard Deviation 1.86
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 4-0.8 Grams per liter (g/L)Standard Deviation 2.4
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 2-1.4 Grams per liter (g/L)Standard Deviation 4.17
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 7-1.9 Grams per liter (g/L)Standard Deviation 1.81
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 8-1.7 Grams per liter (g/L)Standard Deviation 1.75
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Baseline71.0 Grams per liter (g/L)Standard Deviation 3.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 7-2.8 Grams per liter (g/L)Standard Deviation 2.76
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 82.76 Grams per liter (g/L)Standard Deviation 2.86
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 10-8.0 Grams per liter (g/L)Standard Deviation 0
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 4-1.0 Grams per liter (g/L)Standard Deviation 3.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 161.0 Grams per liter (g/L)Standard Deviation 3.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 240.1 Grams per liter (g/L)Standard Deviation 2.17
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Baseline128.3 Grams per liter (g/L)Standard Deviation 15.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 40.4 Grams per liter (g/L)Standard Deviation 6.55
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Baseline43.9 Grams per liter (g/L)Standard Deviation 3
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 10-5.5 Grams per liter (g/L)Standard Deviation 0.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 14-1.0 Grams per liter (g/L)Standard Deviation 1.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 4-0.1 Grams per liter (g/L)Standard Deviation 2.1
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 160.8 Grams per liter (g/L)Standard Deviation 2.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 24-0.3 Grams per liter (g/L)Standard Deviation 1.04
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 31.3 Grams per liter (g/L)Standard Deviation 3.93
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 40.0 Grams per liter (g/L)Standard Deviation 4.43
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 14-1.6 Grams per liter (g/L)Standard Deviation 2.56
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Baseline142.4 Grams per liter (g/L)Standard Deviation 15.67
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 43.9 Grams per liter (g/L)Standard Deviation 5.46
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 4-1.4 Grams per liter (g/L)Standard Deviation 4.96
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 2-0.3 Grams per liter (g/L)Standard Deviation 1.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 24-1.4 Grams per liter (g/L)Standard Deviation 13.99
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 23.9 Grams per liter (g/L)Standard Deviation 6.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Baseline43.9 Grams per liter (g/L)Standard Deviation 3.44
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 24-1.9 Grams per liter (g/L)Standard Deviation 2.48
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Week 16-3.4 Grams per liter (g/L)Standard Deviation 4.12
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 34.3 Grams per liter (g/L)Standard Deviation 5.39
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 2-1.5 Grams per liter (g/L)Standard Deviation 3.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 14-0.1 Grams per liter (g/L)Standard Deviation 1.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 7-0.1 Grams per liter (g/L)Standard Deviation 3.52
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 14-0.4 Grams per liter (g/L)Standard Deviation 4.47
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 40.6 Grams per liter (g/L)Standard Deviation 2.2
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 14-0.8 Grams per liter (g/L)Standard Deviation 2.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Baseline72.3 Grams per liter (g/L)Standard Deviation 4.4
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 4-0.3 Grams per liter (g/L)Standard Deviation 2.43
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 4-1.9 Grams per liter (g/L)Standard Deviation 3.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 70.4 Grams per liter (g/L)Standard Deviation 2
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinHemoglobin, at Day 7-0.4 Grams per liter (g/L)Standard Deviation 4.37
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 16-4.4 Grams per liter (g/L)Standard Deviation 3.87
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 40.3 Grams per liter (g/L)Standard Deviation 1.58
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Day 3-1.9 Grams per liter (g/L)Standard Deviation 3.04
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinTotal Protein, at Week 24-2.7 Grams per liter (g/L)Standard Deviation 4.46
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Day 3-0.1 Grams per liter (g/L)Standard Deviation 1.73
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Hemoglobin, Albumin and Total ProteinAlbumin, at Week 16-2.0 Grams per liter (g/L)Standard Deviation 2.16
Secondary

Change From Baseline in Mean Corpuscle Hemoglobin (MCH)

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Baseline29.05 picograms (pg)Standard Deviation 1.028
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 4-0.09 picograms (pg)Standard Deviation 0.608
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 7-0.36 picograms (pg)Standard Deviation 0.302
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 24-0.39 picograms (pg)Standard Deviation 1.051
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 14-0.06 picograms (pg)Standard Deviation 0.475
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 20.20 picograms (pg)Standard Deviation 0.553
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 16-0.21 picograms (pg)Standard Deviation 0.613
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 10-0.20 picograms (pg)Standard Deviation 0.141
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 240.39 picograms (pg)Standard Deviation 0.716
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Baseline28.33 picograms (pg)Standard Deviation 2.213
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 20.21 picograms (pg)Standard Deviation 0.458
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 30.63 picograms (pg)Standard Deviation 0.836
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 40.67 picograms (pg)Standard Deviation 0.463
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 70.16 picograms (pg)Standard Deviation 0.385
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 80.27 picograms (pg)Standard Deviation 0.48
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 140.44 picograms (pg)Standard Deviation 0.524
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 40.39 picograms (pg)Standard Deviation 0.617
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 160.39 picograms (pg)Standard Deviation 0.779
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 40.55 picograms (pg)Standard Deviation 0.678
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 240.31 picograms (pg)Standard Deviation 1.524
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 40.16 picograms (pg)Standard Deviation 0.466
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 30.39 picograms (pg)Standard Deviation 0.29
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Baseline29.26 picograms (pg)Standard Deviation 1.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Week 160.24 picograms (pg)Standard Deviation 0.737
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 70.29 picograms (pg)Standard Deviation 0.536
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 2-0.08 picograms (pg)Standard Deviation 0.345
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Hemoglobin (MCH)Day 140.33 picograms (pg)Standard Deviation 0.59
Secondary

Change From Baseline in Mean Corpuscle Volume (MCV)

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Baseline85.78 cubic micronsStandard Deviation 2.013
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 20.14 cubic micronsStandard Deviation 0.466
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 70.84 cubic micronsStandard Deviation 0.661
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 140.06 cubic micronsStandard Deviation 0.784
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 4-0.53 cubic micronsStandard Deviation 1.216
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 160.76 cubic micronsStandard Deviation 0.842
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 241.34 cubic micronsStandard Deviation 1.983
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 16-0.75 cubic micronsStandard Deviation 2.522
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 40.34 cubic micronsStandard Deviation 1.125
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 8-0.27 cubic micronsStandard Deviation 0.674
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Baseline86.89 cubic micronsStandard Deviation 6.081
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 100.05 cubic micronsStandard Deviation 0.354
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 24-0.41 cubic micronsStandard Deviation 2.107
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 2-0.66 cubic micronsStandard Deviation 0.478
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 7-0.61 cubic micronsStandard Deviation 0.562
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 3-0.72 cubic micronsStandard Deviation 0.492
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 140.04 cubic micronsStandard Deviation 0.746
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 4-1.38 cubic micronsStandard Deviation 0.542
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 140.06 cubic micronsStandard Deviation 0.623
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 4-0.41 cubic micronsStandard Deviation 0.589
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 4-0.03 cubic micronsStandard Deviation 0.703
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 7-0.10 cubic micronsStandard Deviation 0.469
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 160.74 cubic micronsStandard Deviation 1.078
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 3-0.03 cubic micronsStandard Deviation 0.345
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Week 240.40 cubic micronsStandard Deviation 2.195
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Baseline87.28 cubic micronsStandard Deviation 3.478
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Mean Corpuscle Volume (MCV)Day 2-0.03 cubic micronsStandard Deviation 0.354
Secondary

Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 14-0.340 10^9 cells/LStandard Deviation 0.7531
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 14-0.019 10^9 cells/LStandard Deviation 0.1664
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 20.315 10^9 cells/LStandard Deviation 0.8333
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 70.11 10^9 cells/LStandard Deviation 0.872
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 140.059 10^9 cells/LStandard Deviation 0.0718
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Baseline0.033 10^9 cells/LStandard Deviation 0.0139
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 71.4 10^9 cells/LStandard Deviation 13.65
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 4-0.160 10^9 cells/LStandard Deviation 1.2887
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 14-0.26 10^9 cells/LStandard Deviation 0.809
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 40.036 10^9 cells/LStandard Deviation 0.1061
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 20.091 10^9 cells/LStandard Deviation 0.1037
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 4-0.03 10^9 cells/LStandard Deviation 1.261
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 16-0.178 10^9 cells/LStandard Deviation 0.6481
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 1419.9 10^9 cells/LStandard Deviation 32.89
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 2-0.004 10^9 cells/LStandard Deviation 0.0092
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 24-0.46 10^9 cells/LStandard Deviation 0.883
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 20.018 10^9 cells/LStandard Deviation 0.0851
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 70.066 10^9 cells/LStandard Deviation 0.8177
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Baseline1.368 10^9 cells/LStandard Deviation 0.268
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 430.6 10^9 cells/LStandard Deviation 87.1
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 160.01 10^9 cells/LStandard Deviation 0.892
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 20.006 10^9 cells/LStandard Deviation 0.1908
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Baseline0.121 10^9 cells/LStandard Deviation 0.0957
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 241.1 10^9 cells/LStandard Deviation 27.58
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 24-0.535 10^9 cells/LStandard Deviation 0.8511
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 24-0.018 10^9 cells/LStandard Deviation 0.1099
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 40.045 10^9 cells/LStandard Deviation 0.0644
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 140.034 10^9 cells/LStandard Deviation 0.1347
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Baseline256.3 10^9 cells/LStandard Deviation 48.96
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 160.059 10^9 cells/LStandard Deviation 0.1667
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 16-0.001 10^9 cells/LStandard Deviation 0.0083
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 40.063 10^9 cells/LStandard Deviation 0.1943
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 240.000 10^9 cells/LStandard Deviation 0.0151
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 70.008 10^9 cells/LStandard Deviation 0.0128
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 160.100 10^9 cells/LStandard Deviation 0.2441
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 240.001 10^9 cells/LStandard Deviation 0.1063
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 70.016 10^9 cells/LStandard Deviation 0.0964
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 240.058 10^9 cells/LStandard Deviation 0.3377
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 26.6 10^9 cells/LStandard Deviation 12.7
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 140.001 10^9 cells/LStandard Deviation 0.0064
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Baseline0.396 10^9 cells/LStandard Deviation 0.1556
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Baseline5.13 10^9 cells/LStandard Deviation 1.161
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Baseline3.218 10^9 cells/LStandard Deviation 0.9157
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 7-0.043 10^9 cells/LStandard Deviation 0.1763
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 16-0.5 10^9 cells/LStandard Deviation 19.34
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 40.003 10^9 cells/LStandard Deviation 0.0139
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 20.43 10^9 cells/LStandard Deviation 0.696
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 160.023 10^9 cells/LStandard Deviation 0.063
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 70.049 10^9 cells/LStandard Deviation 0.1185
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 7-0.04 10^9 cells/LStandard Deviation 1.171
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 8-0.05 10^9 cells/LStandard Deviation 0.997
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 10-0.85 10^9 cells/LStandard Deviation 0.071
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 14-0.38 10^9 cells/LStandard Deviation 0.791
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Baseline0.035 10^9 cells/LStandard Deviation 0.0207
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 4-0.40 10^9 cells/LStandard Deviation 0.857
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 40.32 10^9 cells/LStandard Deviation 1.386
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 240.40 10^9 cells/LStandard Deviation 2.438
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 20.000 10^9 cells/LStandard Deviation 0.0151
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Baseline2.214 10^9 cells/LStandard Deviation 0.5545
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 2-0.484 10^9 cells/LStandard Deviation 0.3503
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 30.005 10^9 cells/LStandard Deviation 0.0152
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 3-0.175 10^9 cells/LStandard Deviation 0.3459
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 16-0.63 10^9 cells/LStandard Deviation 1.073
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 4-0.065 10^9 cells/LStandard Deviation 0.3551
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 40.012 10^9 cells/LStandard Deviation 0.0172
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 8-0.193 10^9 cells/LStandard Deviation 0.3462
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 10-0.475 10^9 cells/LStandard Deviation 0.0778
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 80.002 10^9 cells/LStandard Deviation 0.0098
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 4-0.314 10^9 cells/LStandard Deviation 0.2911
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 16-0.190 10^9 cells/LStandard Deviation 0.2478
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 100.000 10^9 cells/LStandard Deviation 0.0283
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 24-0.380 10^9 cells/LStandard Deviation 0.3497
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Baseline0.461 10^9 cells/LStandard Deviation 0.1038
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 140.008 10^9 cells/LStandard Deviation 0.0139
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 30.040 10^9 cells/LStandard Deviation 0.0639
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 40.080 10^9 cells/LStandard Deviation 0.0957
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 40.004 10^9 cells/LStandard Deviation 0.0141
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 30.13 10^9 cells/LStandard Deviation 1.113
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 7-0.211 10^9 cells/LStandard Deviation 0.3189
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 80.008 10^9 cells/LStandard Deviation 0.1019
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 10-0.110 10^9 cells/LStandard Deviation 0.1131
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 14-0.078 10^9 cells/LStandard Deviation 0.1237
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 4-0.045 10^9 cells/LStandard Deviation 0.1146
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 160.004 10^9 cells/LStandard Deviation 0.0192
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 16-0.029 10^9 cells/LStandard Deviation 0.1221
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 240.001 10^9 cells/LStandard Deviation 0.167
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Baseline0.098 10^9 cells/LStandard Deviation 0.0333
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Baseline3.499 10^9 cells/LStandard Deviation 0.9783
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 20.214 10^9 cells/LStandard Deviation 1.0869
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 30.238 10^9 cells/LStandard Deviation 0.9621
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 20.010 10^9 cells/LStandard Deviation 0.0151
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 40.262 10^9 cells/LStandard Deviation 1.073
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 14-0.386 10^9 cells/LStandard Deviation 0.3366
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 80.160 10^9 cells/LStandard Deviation 0.8802
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 10-0.270 10^9 cells/LStandard Deviation 0.3111
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 140.096 10^9 cells/LStandard Deviation 0.8912
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 30.017 10^9 cells/LStandard Deviation 0.0121
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 4-0.036 10^9 cells/LStandard Deviation 0.9269
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 16-0.468 10^9 cells/LStandard Deviation 0.9437
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 40.022 10^9 cells/LStandard Deviation 0.0194
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 240.691 10^9 cells/LStandard Deviation 2.3541
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 2-0.048 10^9 cells/LStandard Deviation 0.1159
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Baseline301.9 10^9 cells/LStandard Deviation 34.84
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 2-14.6 10^9 cells/LStandard Deviation 12.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 70.000 10^9 cells/LStandard Deviation 0.0293
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 33.2 10^9 cells/LStandard Deviation 19.77
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 10-0.010 10^9 cells/LStandard Deviation 0.0424
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 4-4.2 10^9 cells/LStandard Deviation 17.22
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 70.0 10^9 cells/LStandard Deviation 13.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 140.011 10^9 cells/LStandard Deviation 0.0624
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 82.8 10^9 cells/LStandard Deviation 12.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 10-8.0 10^9 cells/LStandard Deviation 19.8
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 141.0 10^9 cells/LStandard Deviation 52.6
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 4-3.5 10^9 cells/LStandard Deviation 15.1
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 2412.5 10^9 cells/LStandard Deviation 37.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 70.003 10^9 cells/LStandard Deviation 0.0128
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 40.001 10^9 cells/LStandard Deviation 0.029
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 70.210 10^9 cells/LStandard Deviation 0.9063
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 160.053 10^9 cells/LStandard Deviation 0.1269
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 240.094 10^9 cells/LStandard Deviation 0.1445
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 80.003 10^9 cells/LStandard Deviation 0.032
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Baseline6.31 10^9 cells/LStandard Deviation 1.365
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 2-0.31 10^9 cells/LStandard Deviation 1.253
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 166.6 10^9 cells/LStandard Deviation 35.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 7-0.021 10^9 cells/LStandard Deviation 0.1572
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 240.001 10^9 cells/LStandard Deviation 0.0259
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 24-2.3 10^9 cells/LStandard Deviation 27.79
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 7-0.005 10^9 cells/LStandard Deviation 0.0107
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 16-0.001 10^9 cells/LStandard Deviation 0.0121
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 24-0.013 10^9 cells/LStandard Deviation 0.016
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 70.016 10^9 cells/LStandard Deviation 0.0619
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 3-0.41 10^9 cells/LStandard Deviation 1.089
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 4-0.106 10^9 cells/LStandard Deviation 0.3847
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 7-0.079 10^9 cells/LStandard Deviation 1.848
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 43.1 10^9 cells/LStandard Deviation 31.31
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Week 16-6.4 10^9 cells/LStandard Deviation 31.43
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Baseline0.044 10^9 cells/LStandard Deviation 0.0106
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 2-0.009 10^9 cells/LStandard Deviation 0.0083
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 3-0.009 10^9 cells/LStandard Deviation 0.0113
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 4-0.001 10^9 cells/LStandard Deviation 0.0181
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Day 140.003 10^9 cells/LStandard Deviation 0.0149
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsBasophils, at Week 40.000 10^9 cells/LStandard Deviation 0.0185
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Baseline0.145 10^9 cells/LStandard Deviation 0.137
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 20.016 10^9 cells/LStandard Deviation 0.0385
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 30.010 10^9 cells/LStandard Deviation 0.0513
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 40.010 10^9 cells/LStandard Deviation 0.0431
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Day 140.025 10^9 cells/LStandard Deviation 0.0444
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 4-0.004 10^9 cells/LStandard Deviation 0.0403
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 160.013 10^9 cells/LStandard Deviation 0.0605
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsEosinophils, at Week 24-0.001 10^9 cells/LStandard Deviation 0.0527
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Baseline6.50 10^9 cells/LStandard Deviation 2.036
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 2-0.36 10^9 cells/LStandard Deviation 0.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 4-0.49 10^9 cells/LStandard Deviation 1.36
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 7-0.25 10^9 cells/LStandard Deviation 2.165
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Day 14-0.25 10^9 cells/LStandard Deviation 0.994
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 4-0.48 10^9 cells/LStandard Deviation 1.34
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 16-0.64 10^9 cells/LStandard Deviation 1.162
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsWBC, at Week 24-0.51 10^9 cells/LStandard Deviation 0.54
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Baseline2.086 10^9 cells/LStandard Deviation 0.4824
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 2-0.094 10^9 cells/LStandard Deviation 0.2147
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 3-0.135 10^9 cells/LStandard Deviation 0.2727
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 7-0.175 10^9 cells/LStandard Deviation 0.3166
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Day 14-0.161 10^9 cells/LStandard Deviation 0.3561
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 4-0.226 10^9 cells/LStandard Deviation 0.2908
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 16-0.191 10^9 cells/LStandard Deviation 0.3559
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsLymphocytes, at Week 24-0.339 10^9 cells/LStandard Deviation 0.4461
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Baseline0.485 10^9 cells/LStandard Deviation 0.1488
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 2-0.008 10^9 cells/LStandard Deviation 0.0587
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 3-0.013 10^9 cells/LStandard Deviation 0.0886
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 4-0.006 10^9 cells/LStandard Deviation 0.1034
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 7-0.013 10^9 cells/LStandard Deviation 0.1413
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Day 14-0.015 10^9 cells/LStandard Deviation 0.1319
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 4-0.034 10^9 cells/LStandard Deviation 0.101
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 160.001 10^9 cells/LStandard Deviation 0.0724
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsMonocytes, at Week 24-0.020 10^9 cells/LStandard Deviation 0.0462
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Baseline3.756 10^9 cells/LStandard Deviation 1.6757
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 2-0.263 10^9 cells/LStandard Deviation 0.9093
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 3-0.291 10^9 cells/LStandard Deviation 0.9503
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 4-0.398 10^9 cells/LStandard Deviation 1.0114
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Day 14-0.116 10^9 cells/LStandard Deviation 0.7571
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 4-0.233 10^9 cells/LStandard Deviation 1.1531
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 16-0.500 10^9 cells/LStandard Deviation 0.9401
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsNeutrophils, at Week 24-0.160 10^9 cells/LStandard Deviation 0.634
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Baseline289.5 10^9 cells/LStandard Deviation 71.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 21.0 10^9 cells/LStandard Deviation 18.48
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 30.1 10^9 cells/LStandard Deviation 19.63
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 4-4.9 10^9 cells/LStandard Deviation 20.16
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 71.9 10^9 cells/LStandard Deviation 23.46
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and BasophilsPlatelets, at Day 142.1 10^9 cells/LStandard Deviation 40.86
Secondary

Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 15.0449
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 49.542 MilisecondsStandard Deviation 5.9038
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 12.833 MilisecondsStandard Deviation 10.057
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 10.708 MilisecondsStandard Deviation 12.1713
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 244.583 MilisecondsStandard Deviation 10.1164
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 78.667 MilisecondsStandard Deviation 22.8341
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 Baseline378.875 MilisecondsStandard Deviation 17.7719
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 Baseline92.875 MilisecondsStandard Deviation 8.1141
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 41.167 MilisecondsStandard Deviation 10.6398
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 40.708 MilisecondsStandard Deviation 3.9337
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 10.875 MilisecondsStandard Deviation 3.5587
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 70.000 MilisecondsStandard Deviation 5.1052
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 2.6693
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 24.750 MilisecondsStandard Deviation 12.1299
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 41.458 MilisecondsStandard Deviation 5.0895
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 2.3363
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 Baseline161.375 MilisecondsStandard Deviation 20.2762
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 242.417 MilisecondsStandard Deviation 10.5991
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 Baseline402.750 MilisecondsStandard Deviation 10.5119
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 10.7157
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 414.083 MilisecondsStandard Deviation 18.0614
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 7.5297
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 31.083 MilisecondsStandard Deviation 7.8493
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 9.2923
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 77.042 MilisecondsStandard Deviation 20.7972
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 44.625 MilisecondsStandard Deviation 8.6179
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 2415.125 MilisecondsStandard Deviation 21.3348
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 45.917 MilisecondsStandard Deviation 22.1616
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 71.458 MilisecondsStandard Deviation 11.6223
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 MilisecondsStandard Deviation 4.5066
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 38.583 MilisecondsStandard Deviation 18.265
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 30.917 MilisecondsStandard Deviation 9.5232
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 721.083 MilisecondsStandard Deviation 21.4755
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 21.917 MilisecondsStandard Deviation 9.5282
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 220.750 MilisecondsStandard Deviation 18.9684
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 2413.167 MilisecondsStandard Deviation 21.5318
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QTcF Interval, at Day 3-1.250 MilisecondsStandard Deviation 14.9047
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 46.500 MilisecondsStandard Deviation 8.8515
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline164.000 MilisecondsStandard Deviation 16.6733
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 33.000 MilisecondsStandard Deviation 10.6354
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 40.875 MilisecondsStandard Deviation 10.8656
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 76.167 MilisecondsStandard Deviation 10.9516
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 85.875 MilisecondsStandard Deviation 9.433
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 1019.167 MilisecondsStandard Deviation 8.721
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 44.250 MilisecondsStandard Deviation 11.77
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)PR Interval, at Week 24-0.958 MilisecondsStandard Deviation 11.6571
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline90.750 MilisecondsStandard Deviation 11.8291
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 2-0.458 MilisecondsStandard Deviation 3.7116
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 3-2.833 MilisecondsStandard Deviation 6.2463
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 4-1.875 MilisecondsStandard Deviation 6.0708
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 7-1.500 MilisecondsStandard Deviation 6.8359
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 MilisecondsStandard Deviation 4.6987
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 MilisecondsStandard Deviation 6.5997
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Week 4-0.958 MilisecondsStandard Deviation 3.8398
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Week 24-0.458 MilisecondsStandard Deviation 4.4755
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline395.875 MilisecondsStandard Deviation 19.1493
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 310.542 MilisecondsStandard Deviation 27.0566
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 47.000 MilisecondsStandard Deviation 27.0725
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 819.167 MilisecondsStandard Deviation 20.0206
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 1031.667 MilisecondsStandard Deviation 55.1543
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 431.167 MilisecondsStandard Deviation 17.0023
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline419.375 MilisecondsStandard Deviation 13.7523
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 21.083 MilisecondsStandard Deviation 15.4486
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QTcF Interval, at Day 4-4.292 MilisecondsStandard Deviation 18.322
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 70.958 MilisecondsStandard Deviation 9.6715
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 81.833 MilisecondsStandard Deviation 14.841
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 100.667 MilisecondsStandard Deviation 33.9411
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 242.229 MilisecondsStandard Deviation 14.8754
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 72.625 MilisecondsStandard Deviation 6.3507
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 23.375 MilisecondsStandard Deviation 11.7924
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 39.792 MilisecondsStandard Deviation 12.7179
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 43.000 MilisecondsStandard Deviation 10.0775
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 32.083 MilisecondsStandard Deviation 8.6295
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 49.167 MilisecondsStandard Deviation 18.5267
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 33.667 MilisecondsStandard Deviation 10.6845
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 23.500 MilisecondsStandard Deviation 7.6677
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 78.500 MilisecondsStandard Deviation 13.6498
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 2415.952 MilisecondsStandard Deviation 10.9771
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 247.238 MilisecondsStandard Deviation 5.6461
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 10.500 MilisecondsStandard Deviation 4.5145
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 42.250 MilisecondsStandard Deviation 8.4867
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 3-2.583 MilisecondsStandard Deviation 3.6764
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 2-3.708 MilisecondsStandard Deviation 5.6833
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline164.875 MilisecondsStandard Deviation 14.2872
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 4-4.458 MilisecondsStandard Deviation 6.4855
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QRS Interval, at Day 1-5.250 MilisecondsStandard Deviation 6.8098
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 73.500 MilisecondsStandard Deviation 11.9004
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 7-2.917 MilisecondsStandard Deviation 6.3164
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline397.000 MilisecondsStandard Deviation 14.8131
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 41.917 MilisecondsStandard Deviation 9.0847
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline100.250 MilisecondsStandard Deviation 12.1155
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 11.375 MilisecondsStandard Deviation 9.178
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 410.583 MilisecondsStandard Deviation 13.7318
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 24-5.238 MilisecondsStandard Deviation 6.4599
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 24-1.905 MilisecondsStandard Deviation 12.0872
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 4-4.708 MilisecondsStandard Deviation 6.2372
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 Baseline380.375 MilisecondsStandard Deviation 12.3513
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 4-2.250 MilisecondsStandard Deviation 10.6231
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)QT Interval, at Day 1-0.625 MilisecondsStandard Deviation 8.662
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 216.083 MilisecondsStandard Deviation 13.6449
Secondary

Change From Baseline in Pulse Rate

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.

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 24-10.5 Beats per minute (Beats/min)Standard Deviation 6.57
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 12-4.8 Beats per minute (Beats/min)Standard Deviation 10.44
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 7-1.4 Beats per minute (Beats/min)Standard Deviation 18.68
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 2-4.4 Beats per minute (Beats/min)Standard Deviation 6.74
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 8-3.9 Beats per minute (Beats/min)Standard Deviation 15.13
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateBaseline73.9 Beats per minute (Beats/min)Standard Deviation 7.85
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 4-7.3 Beats per minute (Beats/min)Standard Deviation 3.28
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 21-3.1 Beats per minute (Beats/min)Standard Deviation 11.43
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 20-9.0 Beats per minute (Beats/min)Standard Deviation 8.14
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 3-7.6 Beats per minute (Beats/min)Standard Deviation 4.84
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 14-4.5 Beats per minute (Beats/min)Standard Deviation 7.6
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 16-11.1 Beats per minute (Beats/min)Standard Deviation 10.25
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 4-6.4 Beats per minute (Beats/min)Standard Deviation 7.76
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 12-6.3 Beats per minute (Beats/min)Standard Deviation 7.44
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 14-10.0 Beats per minute (Beats/min)Standard Deviation 6.72
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateBaseline71.1 Beats per minute (Beats/min)Standard Deviation 7.16
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 2-7.6 Beats per minute (Beats/min)Standard Deviation 8.28
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 3-5.4 Beats per minute (Beats/min)Standard Deviation 9.01
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 4-4.3 Beats per minute (Beats/min)Standard Deviation 8.75
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 7-9.4 Beats per minute (Beats/min)Standard Deviation 6.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 8-8.3 Beats per minute (Beats/min)Standard Deviation 5.78
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 21-9.1 Beats per minute (Beats/min)Standard Deviation 5.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 4-9.9 Beats per minute (Beats/min)Standard Deviation 7.34
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 8-8.0 Beats per minute (Beats/min)Standard Deviation 8.09
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 10-12.0 Beats per minute (Beats/min)Standard Deviation 7.07
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 16-5.1 Beats per minute (Beats/min)Standard Deviation 8.61
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 20-5.0 Beats per minute (Beats/min)Standard Deviation 5.01
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 24-4.3 Beats per minute (Beats/min)Standard Deviation 4.8
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 8-8.3 Beats per minute (Beats/min)Standard Deviation 15.75
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 4-8.1 Beats per minute (Beats/min)Standard Deviation 11.52
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 20-12.4 Beats per minute (Beats/min)Standard Deviation 8.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 12-9.8 Beats per minute (Beats/min)Standard Deviation 14.21
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 3-12.1 Beats per minute (Beats/min)Standard Deviation 8.63
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateBaseline75.9 Beats per minute (Beats/min)Standard Deviation 12.26
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 16-10.6 Beats per minute (Beats/min)Standard Deviation 10.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 21-11.0 Beats per minute (Beats/min)Standard Deviation 18.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 14-11.4 Beats per minute (Beats/min)Standard Deviation 16.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 2-13.8 Beats per minute (Beats/min)Standard Deviation 10.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 4-13.4 Beats per minute (Beats/min)Standard Deviation 12.05
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateDay 7-8.4 Beats per minute (Beats/min)Standard Deviation 14.81
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Pulse RateWeek 24-15.3 Beats per minute (Beats/min)Standard Deviation 11.5
Secondary

Change From Baseline in Red Blood Cell Count (RBC)

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Baseline4.518 Trillion cells/L (TI/L)Standard Deviation 0.5518
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 70.155 Trillion cells/L (TI/L)Standard Deviation 0.2067
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 140.130 Trillion cells/L (TI/L)Standard Deviation 0.1646
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 20.180 Trillion cells/L (TI/L)Standard Deviation 0.2654
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 160.186 Trillion cells/L (TI/L)Standard Deviation 0.2612
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 40.050 Trillion cells/L (TI/L)Standard Deviation 0.1802
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 240.063 Trillion cells/L (TI/L)Standard Deviation 0.1496
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 30.163 Trillion cells/L (TI/L)Standard Deviation 0.3064
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 40.085 Trillion cells/L (TI/L)Standard Deviation 0.2239
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 70.084 Trillion cells/L (TI/L)Standard Deviation 0.1584
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 80.088 Trillion cells/L (TI/L)Standard Deviation 0.1877
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 10-0.315 Trillion cells/L (TI/L)Standard Deviation 0.1626
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 14-0.088 Trillion cells/L (TI/L)Standard Deviation 0.194
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 4-0.026 Trillion cells/L (TI/L)Standard Deviation 0.1625
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 240.078 Trillion cells/L (TI/L)Standard Deviation 0.2326
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Baseline4.523 Trillion cells/L (TI/L)Standard Deviation 0.4014
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 20.043 Trillion cells/L (TI/L)Standard Deviation 0.1717
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 160.124 Trillion cells/L (TI/L)Standard Deviation 0.2212
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 30.079 Trillion cells/L (TI/L)Standard Deviation 0.189
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 24-0.110 Trillion cells/L (TI/L)Standard Deviation 0.3089
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 40.056 Trillion cells/L (TI/L)Standard Deviation 0.2169
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 20.141 Trillion cells/L (TI/L)Standard Deviation 0.2154
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Baseline4.889 Trillion cells/L (TI/L)Standard Deviation 0.6362
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 4-0.078 Trillion cells/L (TI/L)Standard Deviation 0.1814
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 14-0.064 Trillion cells/L (TI/L)Standard Deviation 0.1686
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Week 16-0.164 Trillion cells/L (TI/L)Standard Deviation 0.0752
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Red Blood Cell Count (RBC)Day 7-0.074 Trillion cells/L (TI/L)Standard Deviation 0.1429
Secondary

Change From Baseline in Respiratory Rate

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.

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 41.3 Breaths per minute (Breaths/min)Standard Deviation 2.38
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 21-1.3 Breaths per minute (Breaths/min)Standard Deviation 2.6
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 4-2.0 Breaths per minute (Breaths/min)Standard Deviation 2.14
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 16-2.0 Breaths per minute (Breaths/min)Standard Deviation 4.28
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 14-1.5 Breaths per minute (Breaths/min)Standard Deviation 2.98
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 70.8 Breaths per minute (Breaths/min)Standard Deviation 4.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/4 Hours Postdose-1.4 Breaths per minute (Breaths/min)Standard Deviation 1.9
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 3-1.3 Breaths per minute (Breaths/min)Standard Deviation 2.12
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 20-0.9 Breaths per minute (Breaths/min)Standard Deviation 3.8
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 12-1.0 Breaths per minute (Breaths/min)Standard Deviation 2.14
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/8 Hours Postdose1.5 Breaths per minute (Breaths/min)Standard Deviation 2.56
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateBaseline15.5 Breaths per minute (Breaths/min)Standard Deviation 1.41
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 81.0 Breaths per minute (Breaths/min)Standard Deviation 2.83
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 2-1.3 Breaths per minute (Breaths/min)Standard Deviation 3.2
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 24-3.3 Breaths per minute (Breaths/min)Standard Deviation 2.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 8-0.8 Breaths per minute (Breaths/min)Standard Deviation 5.01
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 3-1.5 Breaths per minute (Breaths/min)Standard Deviation 4.24
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateBaseline15.8 Breaths per minute (Breaths/min)Standard Deviation 3.77
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/4 Hours Postdose-0.3 Breaths per minute (Breaths/min)Standard Deviation 3.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/8 Hours Postdose-2.3 Breaths per minute (Breaths/min)Standard Deviation 2.25
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 2-2.0 Breaths per minute (Breaths/min)Standard Deviation 3.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 4-1.5 Breaths per minute (Breaths/min)Standard Deviation 3.16
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 7-2.8 Breaths per minute (Breaths/min)Standard Deviation 4.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 100.0 Breaths per minute (Breaths/min)Standard Deviation 5.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 14-2.0 Breaths per minute (Breaths/min)Standard Deviation 3.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 21-2.3 Breaths per minute (Breaths/min)Standard Deviation 2.92
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 4-2.0 Breaths per minute (Breaths/min)Standard Deviation 4.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 8-2.3 Breaths per minute (Breaths/min)Standard Deviation 4.59
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 12-2.5 Breaths per minute (Breaths/min)Standard Deviation 3.34
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 16-2.5 Breaths per minute (Breaths/min)Standard Deviation 5.42
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 20-1.0 Breaths per minute (Breaths/min)Standard Deviation 3.21
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 24-2.5 Breaths per minute (Breaths/min)Standard Deviation 1.77
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 163.1 Breaths per minute (Breaths/min)Standard Deviation 1.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 41.0 Breaths per minute (Breaths/min)Standard Deviation 2.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/8 Hours Postdose0.8 Breaths per minute (Breaths/min)Standard Deviation 3.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 240.3 Breaths per minute (Breaths/min)Standard Deviation 2.93
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 81.3 Breaths per minute (Breaths/min)Standard Deviation 1.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 1/4 Hours Postdose2.0 Breaths per minute (Breaths/min)Standard Deviation 3.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 7-0.3 Breaths per minute (Breaths/min)Standard Deviation 2.92
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 201.1 Breaths per minute (Breaths/min)Standard Deviation 3.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 40.0 Breaths per minute (Breaths/min)Standard Deviation 2.62
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateWeek 121.5 Breaths per minute (Breaths/min)Standard Deviation 2.33
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 14-1.3 Breaths per minute (Breaths/min)Standard Deviation 2.12
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 32.3 Breaths per minute (Breaths/min)Standard Deviation 2.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateBaseline13.8 Breaths per minute (Breaths/min)Standard Deviation 1.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 211.0 Breaths per minute (Breaths/min)Standard Deviation 3.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Respiratory RateDay 21.3 Breaths per minute (Breaths/min)Standard Deviation 2.12
Secondary

Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide

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

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 2-0.6 Millimole per liter (mmol/L)Standard Deviation 2.45
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 24-0.1 Millimole per liter (mmol/L)Standard Deviation 2.36
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 2-0.015594 Millimole per liter (mmol/L)Standard Deviation 0.1041067
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 140.009356 Millimole per liter (mmol/L)Standard Deviation 0.0398698
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 16-0.4 Millimole per liter (mmol/L)Standard Deviation 2.13
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 7-0.5 Millimole per liter (mmol/L)Standard Deviation 1.07
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 4-1.3 Millimole per liter (mmol/L)Standard Deviation 2.38
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 16-0.8 Millimole per liter (mmol/L)Standard Deviation 1.58
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 14-1.6 Millimole per liter (mmol/L)Standard Deviation 1.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 7-0.012475 Millimole per liter (mmol/L)Standard Deviation 0.0533453
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 20.09 Millimole per liter (mmol/L)Standard Deviation 0.242
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 16-0.015594 Millimole per liter (mmol/L)Standard Deviation 0.0842805
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Baseline103.1 Millimole per liter (mmol/L)Standard Deviation 1.81
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 24-0.056138 Millimole per liter (mmol/L)Standard Deviation 0.0861717
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 7-0.5 Millimole per liter (mmol/L)Standard Deviation 1.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 24-0.5 Millimole per liter (mmol/L)Standard Deviation 1.2
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Baseline29.4 Millimole per liter (mmol/L)Standard Deviation 1.77
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 24-1.1 Millimole per liter (mmol/L)Standard Deviation 2.53
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 16-1.3 Millimole per liter (mmol/L)Standard Deviation 1.28
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 20.5 Millimole per liter (mmol/L)Standard Deviation 1.41
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 2-0.4 Millimole per liter (mmol/L)Standard Deviation 2.13
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 41.5 Millimole per liter (mmol/L)Standard Deviation 1.51
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 4-0.9 Millimole per liter (mmol/L)Standard Deviation 2.17
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 7-0.3 Millimole per liter (mmol/L)Standard Deviation 1.39
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Baseline138.8 Millimole per liter (mmol/L)Standard Deviation 1.39
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 16-0.38 Millimole per liter (mmol/L)Standard Deviation 0.413
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 4-0.031188 Millimole per liter (mmol/L)Standard Deviation 0.0739536
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 4-0.16 Millimole per liter (mmol/L)Standard Deviation 0.389
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 24-0.06 Millimole per liter (mmol/L)Standard Deviation 0.245
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 140.3 Millimole per liter (mmol/L)Standard Deviation 0.89
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 14-0.13 Millimole per liter (mmol/L)Standard Deviation 0.381
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 14-1.3 Millimole per liter (mmol/L)Standard Deviation 1.39
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 7-0.30 Millimole per liter (mmol/L)Standard Deviation 0.421
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Baseline4.36 Millimole per liter (mmol/L)Standard Deviation 0.484
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Baseline2.329706 Millimole per liter (mmol/L)Standard Deviation 0.1049575
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 141.0 Millimole per liter (mmol/L)Standard Deviation 2.88
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 8-0.004158 Millimole per liter (mmol/L)Standard Deviation 0.0639356
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 10-0.112275 Millimole per liter (mmol/L)Standard Deviation 0.0882116
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 14-0.034306 Millimole per liter (mmol/L)Standard Deviation 0.0923367
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 4-0.034306 Millimole per liter (mmol/L)Standard Deviation 0.0853291
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 70.3 Millimole per liter (mmol/L)Standard Deviation 1.28
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 100.0 Millimole per liter (mmol/L)Standard Deviation 1.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 20.0 Millimole per liter (mmol/L)Standard Deviation 2
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 70.1 Millimole per liter (mmol/L)Standard Deviation 1.64
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 20.16 Millimole per liter (mmol/L)Standard Deviation 0.325
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 40.00 Millimole per liter (mmol/L)Standard Deviation 0.544
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 40.18 Millimole per liter (mmol/L)Standard Deviation 0.183
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 160.11 Millimole per liter (mmol/L)Standard Deviation 0.189
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 2-0.4 Millimole per liter (mmol/L)Standard Deviation 2.26
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Baseline2.317231 Millimole per liter (mmol/L)Standard Deviation 0.0805028
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 2-0.003119 Millimole per liter (mmol/L)Standard Deviation 0.0983979
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 30.037425 Millimole per liter (mmol/L)Standard Deviation 0.1101762
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 40.008317 Millimole per liter (mmol/L)Standard Deviation 0.1145166
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 7-0.006238 Millimole per liter (mmol/L)Standard Deviation 0.083018
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 160.018713 Millimole per liter (mmol/L)Standard Deviation 0.0751464
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 24-0.031188 Millimole per liter (mmol/L)Standard Deviation 0.0371268
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Baseline27.8 Millimole per liter (mmol/L)Standard Deviation 2.25
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 20.6 Millimole per liter (mmol/L)Standard Deviation 1.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 31.5 Millimole per liter (mmol/L)Standard Deviation 0.84
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 41.3 Millimole per liter (mmol/L)Standard Deviation 1.03
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 81.3 Millimole per liter (mmol/L)Standard Deviation 1.03
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 140.5 Millimole per liter (mmol/L)Standard Deviation 1.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 40.9 Millimole per liter (mmol/L)Standard Deviation 1.64
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 160.3 Millimole per liter (mmol/L)Standard Deviation 0.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 240.4 Millimole per liter (mmol/L)Standard Deviation 1.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Baseline102.1 Millimole per liter (mmol/L)Standard Deviation 2.59
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 3-1.2 Millimole per liter (mmol/L)Standard Deviation 1.94
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 4-1.5 Millimole per liter (mmol/L)Standard Deviation 1.64
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 80.3 Millimole per liter (mmol/L)Standard Deviation 1.75
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 105.5 Millimole per liter (mmol/L)Standard Deviation 2.12
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 141.0 Millimole per liter (mmol/L)Standard Deviation 2.56
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 41.1 Millimole per liter (mmol/L)Standard Deviation 2.47
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 161.5 Millimole per liter (mmol/L)Standard Deviation 1.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 240.6 Millimole per liter (mmol/L)Standard Deviation 2.26
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Baseline4.14 Millimole per liter (mmol/L)Standard Deviation 0.342
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 30.13 Millimole per liter (mmol/L)Standard Deviation 0.372
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 70.29 Millimole per liter (mmol/L)Standard Deviation 0.47
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 80.07 Millimole per liter (mmol/L)Standard Deviation 0.207
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 100.45 Millimole per liter (mmol/L)Standard Deviation 0.354
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 140.04 Millimole per liter (mmol/L)Standard Deviation 0.513
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 24-0.03 Millimole per liter (mmol/L)Standard Deviation 0.354
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Baseline137.1 Millimole per liter (mmol/L)Standard Deviation 2.23
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 3-0.8 Millimole per liter (mmol/L)Standard Deviation 0.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 4-1.3 Millimole per liter (mmol/L)Standard Deviation 2.25
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 70.5 Millimole per liter (mmol/L)Standard Deviation 2.2
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 80.3 Millimole per liter (mmol/L)Standard Deviation 1.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 104.5 Millimole per liter (mmol/L)Standard Deviation 4.95
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 41.0 Millimole per liter (mmol/L)Standard Deviation 2.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 161.0 Millimole per liter (mmol/L)Standard Deviation 2.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 240.1 Millimole per liter (mmol/L)Standard Deviation 3.48
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 40.4 Millimole per liter (mmol/L)Standard Deviation 1.06
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 2-0.003119 Millimole per liter (mmol/L)Standard Deviation 0.0983979
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 14-0.009356 Millimole per liter (mmol/L)Standard Deviation 0.0923367
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 160.7 Millimole per liter (mmol/L)Standard Deviation 1.8
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Baseline2.351538 Millimole per liter (mmol/L)Standard Deviation 0.0931159
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 3-0.3 Millimole per liter (mmol/L)Standard Deviation 1.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Week 241.7 Millimole per liter (mmol/L)Standard Deviation 2.21
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 140.6 Millimole per liter (mmol/L)Standard Deviation 1.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 40.9 Millimole per liter (mmol/L)Standard Deviation 1.64
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Baseline4.29 Millimole per liter (mmol/L)Standard Deviation 0.485
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 4-0.1 Millimole per liter (mmol/L)Standard Deviation 1.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 30.14 Millimole per liter (mmol/L)Standard Deviation 0.25
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 70.037425 Millimole per liter (mmol/L)Standard Deviation 0.0442316
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 20.10 Millimole per liter (mmol/L)Standard Deviation 0.366
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 7-0.01 Millimole per liter (mmol/L)Standard Deviation 0.34
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 40.3 Millimole per liter (mmol/L)Standard Deviation 1.28
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 3-0.5 Millimole per liter (mmol/L)Standard Deviation 0.93
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 40.003119 Millimole per liter (mmol/L)Standard Deviation 0.0826826
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 70.8 Millimole per liter (mmol/L)Standard Deviation 1.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 14-0.4 Millimole per liter (mmol/L)Standard Deviation 1.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 20.4 Millimole per liter (mmol/L)Standard Deviation 1.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Day 20.1 Millimole per liter (mmol/L)Standard Deviation 2.3
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 40.0 Millimole per liter (mmol/L)Standard Deviation 0.93
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Baseline28.6 Millimole per liter (mmol/L)Standard Deviation 1.92
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 242.0 Millimole per liter (mmol/L)Standard Deviation 2.24
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 16-0.4 Millimole per liter (mmol/L)Standard Deviation 0.98
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 24-0.053464 Millimole per liter (mmol/L)Standard Deviation 0.1002445
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 140.09 Millimole per liter (mmol/L)Standard Deviation 0.458
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Week 240.3 Millimole per liter (mmol/L)Standard Deviation 1.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Week 16-0.064157 Millimole per liter (mmol/L)Standard Deviation 0.0496021
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 16-0.04 Millimole per liter (mmol/L)Standard Deviation 0.382
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Baseline102.4 Millimole per liter (mmol/L)Standard Deviation 2.2
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 20.1 Millimole per liter (mmol/L)Standard Deviation 2.42
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Week 161.3 Millimole per liter (mmol/L)Standard Deviation 1.6
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 3-0.3 Millimole per liter (mmol/L)Standard Deviation 2.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 240.01 Millimole per liter (mmol/L)Standard Deviation 0.308
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 4-0.4 Millimole per liter (mmol/L)Standard Deviation 2.39
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 70.5 Millimole per liter (mmol/L)Standard Deviation 2.14
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Week 4-0.01 Millimole per liter (mmol/L)Standard Deviation 0.196
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCarbon Dioxide, at Day 70.3 Millimole per liter (mmol/L)Standard Deviation 0.71
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 40.040544 Millimole per liter (mmol/L)Standard Deviation 0.07297
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideSodium, at Baseline136.9 Millimole per liter (mmol/L)Standard Deviation 2.53
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideChloride, at Day 140.4 Millimole per liter (mmol/L)Standard Deviation 2.13
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxideCalcium, at Day 30.003119 Millimole per liter (mmol/L)Standard Deviation 0.0759557
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon DioxidePotassium, at Day 40.13 Millimole per liter (mmol/L)Standard Deviation 0.32
Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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.

Time frame: 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 assesses timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 163.8 Millimeters of mercury (mmHg)Standard Deviation 3.15
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 141.6 Millimeters of mercury (mmHg)Standard Deviation 6.63
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 89.0 Millimeters of mercury (mmHg)Standard Deviation 17.02
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 9.2
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 71.9 Millimeters of mercury (mmHg)Standard Deviation 8.32
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 241.5 Millimeters of mercury (mmHg)Standard Deviation 4.28
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 40.6 Millimeters of mercury (mmHg)Standard Deviation 6.05
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 164.6 Millimeters of mercury (mmHg)Standard Deviation 5.55
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 120.5 Millimeters of mercury (mmHg)Standard Deviation 4.96
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 72.1 Millimeters of mercury (mmHg)Standard Deviation 8.18
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Baseline66.5 Millimeters of mercury (mmHg)Standard Deviation 9.71
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 242.0 Millimeters of mercury (mmHg)Standard Deviation 7.78
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 86.4 Millimeters of mercury (mmHg)Standard Deviation 7.74
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Baseline112.8 Millimeters of mercury (mmHg)Standard Deviation 12.67
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 142.4 Millimeters of mercury (mmHg)Standard Deviation 8.68
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 42.1 Millimeters of mercury (mmHg)Standard Deviation 7.24
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 215.4 Millimeters of mercury (mmHg)Standard Deviation 10.21
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 32.4 Millimeters of mercury (mmHg)Standard Deviation 4.87
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 212.8 Millimeters of mercury (mmHg)Standard Deviation 6.5
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 126.8 Millimeters of mercury (mmHg)Standard Deviation 7.15
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Baseline106.3 Millimeters of mercury (mmHg)Standard Deviation 11.68
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 23.5 Millimeters of mercury (mmHg)Standard Deviation 8.04
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 30.8 Millimeters of mercury (mmHg)Standard Deviation 5.99
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 40.3 Millimeters of mercury (mmHg)Standard Deviation 6.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 72.1 Millimeters of mercury (mmHg)Standard Deviation 6.03
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 104.5 Millimeters of mercury (mmHg)Standard Deviation 13.44
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 1411.3 Millimeters of mercury (mmHg)Standard Deviation 9.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 219.8 Millimeters of mercury (mmHg)Standard Deviation 13.36
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 49.5 Millimeters of mercury (mmHg)Standard Deviation 11.8
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 89.5 Millimeters of mercury (mmHg)Standard Deviation 14.43
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 124.5 Millimeters of mercury (mmHg)Standard Deviation 16.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 167.9 Millimeters of mercury (mmHg)Standard Deviation 11.08
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 202.1 Millimeters of mercury (mmHg)Standard Deviation 10.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 246.4 Millimeters of mercury (mmHg)Standard Deviation 10.07
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Baseline59.8 Millimeters of mercury (mmHg)Standard Deviation 6.45
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 23.4 Millimeters of mercury (mmHg)Standard Deviation 8.23
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 31.1 Millimeters of mercury (mmHg)Standard Deviation 7.24
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 4-2.3 Millimeters of mercury (mmHg)Standard Deviation 4.62
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 7-1.6 Millimeters of mercury (mmHg)Standard Deviation 4.41
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 109.0 Millimeters of mercury (mmHg)Standard Deviation 8.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 146.1 Millimeters of mercury (mmHg)Standard Deviation 3.72
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 2110.6 Millimeters of mercury (mmHg)Standard Deviation 8.37
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 48.1 Millimeters of mercury (mmHg)Standard Deviation 6.4
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 89.1 Millimeters of mercury (mmHg)Standard Deviation 3.44
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 169.1 Millimeters of mercury (mmHg)Standard Deviation 5.11
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 206.3 Millimeters of mercury (mmHg)Standard Deviation 5.55
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 247.4 Millimeters of mercury (mmHg)Standard Deviation 6.57
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 3-4.5 Millimeters of mercury (mmHg)Standard Deviation 4.66
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Baseline114.4 Millimeters of mercury (mmHg)Standard Deviation 9.5
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 42.8 Millimeters of mercury (mmHg)Standard Deviation 7.85
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 168.4 Millimeters of mercury (mmHg)Standard Deviation 6.73
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 146.1 Millimeters of mercury (mmHg)Standard Deviation 5.33
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 217.8 Millimeters of mercury (mmHg)Standard Deviation 11.5
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 2-4.5 Millimeters of mercury (mmHg)Standard Deviation 7.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 2112.9 Millimeters of mercury (mmHg)Standard Deviation 4.67
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 146.5 Millimeters of mercury (mmHg)Standard Deviation 10.38
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 2412.1 Millimeters of mercury (mmHg)Standard Deviation 7.49
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 47.6 Millimeters of mercury (mmHg)Standard Deviation 6.32
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 73.6 Millimeters of mercury (mmHg)Standard Deviation 8.28
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 24-0.1 Millimeters of mercury (mmHg)Standard Deviation 4.91
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 206.3 Millimeters of mercury (mmHg)Standard Deviation 7.83
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 2013.6 Millimeters of mercury (mmHg)Standard Deviation 6.19
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Baseline62.1 Millimeters of mercury (mmHg)Standard Deviation 5.59
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 16-0.3 Millimeters of mercury (mmHg)Standard Deviation 10.27
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 87.6 Millimeters of mercury (mmHg)Standard Deviation 3.29
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Day 4-5.6 Millimeters of mercury (mmHg)Standard Deviation 6.23
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 3-1.9 Millimeters of mercury (mmHg)Standard Deviation 5.51
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 127.9 Millimeters of mercury (mmHg)Standard Deviation 11.54
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 2-0.5 Millimeters of mercury (mmHg)Standard Deviation 6.89
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 4-0.8 Millimeters of mercury (mmHg)Standard Deviation 4.86
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Systolic Blood Pressure, at Week 85.6 Millimeters of mercury (mmHg)Standard Deviation 7.58
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Week 1211.5 Millimeters of mercury (mmHg)Standard Deviation 7.78
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Diastolic Blood Pressure, at Day 79.5 Millimeters of mercury (mmHg)Standard Deviation 9.78
Secondary

Change From Baseline in Temperature

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.

Time frame: 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 assessed timepoints and analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 7-0.05 Degrees CelciusStandard Deviation 0.524
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 3-0.23 Degrees CelciusStandard Deviation 0.365
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 4-0.21 Degrees CelciusStandard Deviation 0.364
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 12-0.23 Degrees CelciusStandard Deviation 0.271
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 8-0.28 Degrees CelciusStandard Deviation 0.399
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 20-0.17 Degrees CelciusStandard Deviation 0.315
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureBaseline36.54 Degrees CelciusStandard Deviation 0.233
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 14-0.13 Degrees CelciusStandard Deviation 0.392
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 24-0.19 Degrees CelciusStandard Deviation 0.364
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 21-0.11 Degrees CelciusStandard Deviation 0.554
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 16-0.34 Degrees CelciusStandard Deviation 0.346
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 2-0.10 Degrees CelciusStandard Deviation 0.424
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Change From Baseline in TemperatureDay 4-0.03 Degrees CelciusStandard Deviation 0.311
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 12-0.33 Degrees CelciusStandard Deviation 0.607
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 7-0.41 Degrees CelciusStandard Deviation 0.622
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 4-0.56 Degrees CelciusStandard Deviation 0.534
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 4-0.41 Degrees CelciusStandard Deviation 0.569
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureBaseline36.79 Degrees CelciusStandard Deviation 0.344
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 2-0.48 Degrees CelciusStandard Deviation 0.437
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 3-0.50 Degrees CelciusStandard Deviation 0.475
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 8-0.41 Degrees CelciusStandard Deviation 0.599
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 10-0.60 Degrees CelciusStandard Deviation 0.566
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 14-0.28 Degrees CelciusStandard Deviation 0.492
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 21-0.49 Degrees CelciusStandard Deviation 0.352
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 8-0.45 Degrees CelciusStandard Deviation 0.535
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 16-0.33 Degrees CelciusStandard Deviation 0.575
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 20-0.40 Degrees CelciusStandard Deviation 0.414
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 24-0.55 Degrees CelciusStandard Deviation 0.678
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 8-0.20 Degrees CelciusStandard Deviation 0.566
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 4-0.20 Degrees CelciusStandard Deviation 0.463
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 2-0.14 Degrees CelciusStandard Deviation 0.342
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 12-0.28 Degrees CelciusStandard Deviation 0.423
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureBaseline36.49 Degrees CelciusStandard Deviation 0.5
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 4-0.09 Degrees CelciusStandard Deviation 0.549
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 16-0.69 Degrees CelciusStandard Deviation 0.534
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 3-0.25 Degrees CelciusStandard Deviation 0.454
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 14-0.28 Degrees CelciusStandard Deviation 0.453
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 240.09 Degrees CelciusStandard Deviation 0.367
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 21-0.04 Degrees CelciusStandard Deviation 0.469
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureDay 7-0.04 Degrees CelciusStandard Deviation 0.578
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Change From Baseline in TemperatureWeek 20-0.19 Degrees CelciusStandard Deviation 0.505
Secondary

Maximum Observed Concentration (Cmax) of VH3810109

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

Time frame: 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.

ArmMeasureValue (MEAN)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Maximum Observed Concentration (Cmax) of VH3810109148.2 μg/mL
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Maximum Observed Concentration (Cmax) of VH38101091864 μg/mL
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Maximum Observed Concentration (Cmax) of VH3810109321.1 μg/mL
Secondary

Number of ISRs Events Overall and by Grade (Part 1 and 3)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 4 ISRs0 Number of events
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 5 ISRs0 Number of events
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 3 ISRs7 Number of events
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 2 ISRs5 Number of events
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 1 ISRs2 Number of events
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Overall ISRs14 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 5 ISRs0 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Overall ISRs18 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 1 ISRs6 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 2 ISRs2 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 3 ISRs10 Number of events
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of ISRs Events Overall and by Grade (Part 1 and 3)Grade 4 ISRs0 Number of events
Secondary

Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 27 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 72 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 71 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 70 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 21 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 21 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 75 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 70 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 26 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 21 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 76 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 71 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 71 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 70 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]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 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 24 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 21 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 21 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 76 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 71 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 71 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 71 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 24 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 75 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 72 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 26 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]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 70 Participants
Secondary

Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)A little bothered by pain, Day 22 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Moderately bothered by pain, Day 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Very bothered by pain, Day 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Extremely bothered by pain, Day 20 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)A little bothered by pain, Day 73 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Very bothered by pain, Day 70 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Not at all bothered by pain, Day 26 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Not at all bothered by pain, Day 75 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Moderately bothered by pain, Day 70 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Extremely bothered by pain, Day 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Very bothered by pain, Day 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)A little bothered by pain, Day 22 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Extremely bothered by pain, Day 70 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Not at all bothered by pain, Day 75 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Very bothered by pain, Day 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Not at all bothered by pain, Day 26 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Extremely bothered by pain, Day 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Moderately bothered by pain, Day 20 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)A little bothered by pain, Day 73 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Moderately bothered by pain, Day 70 Participants
Secondary

Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline

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.

Time frame: Day 14 compared with baseline (Day -1)

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 assessed timepoints and analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineLeukocyte esterase0 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineProtein0 Participants
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineGlucose1 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineLeukocyte esterase1 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineGlucose0 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineProtein1 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineLeukocyte esterase1 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineGlucose0 Participants
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Number of Participants With Worst Case Urinalysis at Post-baseline Compared With BaselineProtein1 Participants
Secondary

Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Acceptance of ISRs, Day 21.44 Scores on a scaleStandard Deviation 1.05
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Acceptance of ISRs, Day 71.44 Scores on a scaleStandard Deviation 0.729
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Acceptance of ISRs, Day 71.50 Scores on a scaleStandard Deviation 0.802
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Score Recorded for Acceptance of ISRs, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)Acceptance of ISRs, Day 21.44 Scores on a scaleStandard Deviation 0.496
Secondary

Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 13.63 Scores on a scaleStandard Deviation 2.326
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 23.63 Scores on a scaleStandard Deviation 2.615
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 73.63 Scores on a scaleStandard Deviation 2.925
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 12.75 Scores on a scaleStandard Deviation 2.55
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 20.63 Scores on a scaleStandard Deviation 0.744
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)Day 70.38 Scores on a scaleStandard Deviation 0.744
Secondary

Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)Day 10.50 Scores on a scaleStandard Deviation 1.069
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)Day 20.88 Scores on a scaleStandard Deviation 1.642
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)Day 70.50 Scores on a scaleStandard Deviation 1.414
Secondary

The Overall Duration of ISRs, Expressed in Days

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]The Overall Duration of ISRs, Expressed in Days2.9 DaysStandard Deviation 1.35
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]The Overall Duration of ISRs, Expressed in Days4.6 DaysStandard Deviation 6.29
Secondary

Time of Maximum Observed Concentration (Tmax) of VH3810109

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

Time frame: 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.

ArmMeasureValue (MEAN)
Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Time of Maximum Observed Concentration (Tmax) of VH38101094.503 Days
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Time of Maximum Observed Concentration (Tmax) of VH38101090.046 Days
Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Time of Maximum Observed Concentration (Tmax) of VH38101092.882 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026