HIV Infections
Conditions
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
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3) | Up to Week 24 | 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. |
| Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3) | Up to Week 24 | 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. |
| Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3) | Up to 7 days post-dose | ISRs 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 24 | 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. |
| Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2) | Up to Week 24 | 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. |
| Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2) | Up to Week 24 | 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. |
| Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2) | Up to Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3) | At Day 2 and Day 7 | 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. |
| 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 7 | 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. |
| 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 7 | 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). |
| 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 7 | 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). |
| Number of ISRs Events Overall and by Grade (Part 1 and 3) | Up to day 14 | 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. |
| The Overall Duration of ISRs, Expressed in Days | From Day 1 up to Day 14 | ISRs 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 Basophils | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Change From Baseline in Hematocrit | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Change From Baseline in Hemoglobin, Albumin and Total Protein | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Change From Baseline in Red Blood Cell Count (RBC) | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109 | Up to Week 24 | Blood 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 24 | Blood 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 Bilirubin | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Day 14 compared with baseline (Day -1) | Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis. |
| 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 24 | ECG values were collected as assessed by protocol, at the indicated time points. |
| Change From Baseline in Temperature | From Baseline (Day -1) up to Week 24 | Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions. |
| Change From Baseline in Pulse Rate | From Baseline (Day -1) up to Week 24 | Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions. |
| Change From Baseline in Respiratory Rate | From Baseline (Day -1) up to Week 24 | Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | From Baseline (Day -1) up to Week 24 | Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions. |
| Change From Baseline in Mean Corpuscle Volume (MCV) | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
| AUC From Time Zero to Time t (AUC[0-t]) of VH3810109 | Up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109. |
| Maximum Observed Concentration (Cmax) of VH3810109 | Up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109. |
| Time of Maximum Observed Concentration (Tmax) of VH3810109 | Up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109. |
| Apparent Terminal Phase Half-life (t1/2) of VH3810109 | Up to Week 24 | Blood 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 7 | 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. |
| Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | From Baseline (Day -1) up to Week 24 | Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 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, Continuous | 42.8 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 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 8 / 8 | 1 / 8 | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Group | Value (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 3 | 0 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 2 | 0 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 4 | 0 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 2 | 0 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 3 | 0 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 4 | 0 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 3 | 0 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 4 | 0 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 2 | 0 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 3 | 0 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 2 | 0 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 4 | 0 Participants |
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.
| Arm | Measure | Group | Value (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 3 | 0 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 2 | 0 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 4 | 0 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 2 | 0 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 3 | 0 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 4 | 0 Participants |
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Apparent Terminal Phase Half-life (t1/2) of VH3810109 | 38.17 Days |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Apparent Terminal Phase Half-life (t1/2) of VH3810109 | 46.97 Days |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Apparent Terminal Phase Half-life (t1/2) of VH3810109 | 44.95 Days |
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.
| Arm | Measure | Value (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 VH3810109 | 7587 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 VH3810109 | 31560 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 VH3810109 | 12840 Day*microgram/mililitre (day*μg/mL) |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | AUC From Time Zero to Time t (AUC[0-t]) of VH3810109 | 6996 day*μg/mL |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | AUC From Time Zero to Time t (AUC[0-t]) of VH3810109 | 29160 day*μg/mL |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | AUC From Time Zero to Time t (AUC[0-t]) of VH3810109 | 11590 day*μg/mL |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Day 14 | 1.0 International Units per liter (IU/L) | Standard Deviation 1.41 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALP, at Day 2 | 2.9 International Units per liter (IU/L) | Standard Deviation 3.83 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Week 16 | 2.9 International Units per liter (IU/L) | Standard Deviation 1.81 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Week 4 | 4.3 International Units per liter (IU/L) | Standard Deviation 6.34 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALP, at Week 16 | 4.8 International Units per liter (IU/L) | Standard Deviation 5.23 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Week 4 | 3.0 International Units per liter (IU/L) | Standard Deviation 3.51 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Week 16 | 4.4 International Units per liter (IU/L) | Standard Deviation 2.72 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Baseline | 11.8 International Units per liter (IU/L) | Standard Deviation 2.71 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Day 14 | 1.9 International Units per liter (IU/L) | Standard Deviation 2.03 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Week 24 | 2.0 International Units per liter (IU/L) | Standard Deviation 4.44 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALP, at Week 4 | 0.6 International Units per liter (IU/L) | Standard Deviation 6.5 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Day 7 | 2.8 International Units per liter (IU/L) | Standard Deviation 2.82 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Baseline | 14.5 International Units per liter (IU/L) | Standard Deviation 2.39 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALP, at Day 14 | 7.6 International Units per liter (IU/L) | Standard Deviation 2.97 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | AST, at Day 2 | 0.4 International Units per liter (IU/L) | Standard Deviation 2 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALP, at Day 7 | 4.6 International Units per liter (IU/L) | Standard Deviation 2.77 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP) | ALT, at Day 7 | 1.5 International Units per liter (IU/L) | Standard Deviation 2.83 |
| 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 Baseline | 54.6 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 2 | 0.6 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 24 | 2.0 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 2 | 0.6 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 14 | 4.4 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 Baseline | 12.5 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 3 | 0.5 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 4 | 0.5 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 7 | 0.5 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 8 | 0.8 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 14 | 0.6 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 4 | 1.6 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 16 | 1.4 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 24 | 1.3 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 Baseline | 16.0 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 2 | 1.4 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 3 | 2.7 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 4 | 1.8 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 7 | 0.8 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 8 | 1.0 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 14 | 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 Week 4 | 4.3 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 16 | 1.1 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 24 | 0.1 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 Baseline | 55.9 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 3 | 4.7 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 4 | 4.0 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 7 | 5.9 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 8 | 6.8 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 4 | 7.9 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 16 | 5.4 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 24 | 3.3 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 14 | 2.8 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 16 | 0.4 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 Baseline | 57.1 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 7 | 2.0 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 Baseline | 20.0 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 Baseline | 18.1 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 3 | 0.0 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 4 | 0.5 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 4 | 3.0 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 7 | 2.5 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 24 | 1.6 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 7 | 4.9 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 16 | 1.0 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 4 | 0.0 International Units per liter (IU/L) | Standard Deviation 4.38 |
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.
| Arm | Measure | Group | Value (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 Bilirubin | Glucose, at Baseline | 5.009778 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 Bilirubin | Glucose, 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 Bilirubin | Glucose, at Day 7 | 0.180408 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 Bilirubin | Glucose, 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 Bilirubin | Glucose, at Week 4 | 0.027755 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 Bilirubin | Glucose, 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 Bilirubin | Blood urea nitrogen, at Day 14 | 0.02678 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 Bilirubin | Blood urea nitrogen, at Week 4 | 0.31684 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 Bilirubin | Creatinine, at Baseline | 68.2890 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 Bilirubin | Creatinine, at Day 2 | 1.4365 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 Bilirubin | Creatinine, at Day 7 | 0.0000 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 Bilirubin | Creatinine, at Day 14 | 0.1105 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 Bilirubin | Creatinine, 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 Bilirubin | Creatinine, at Week 24 | 2.0995 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 Bilirubin | Direct Bilirubin, at Baseline | 2.0306 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Total bilirubin, at Baseline | 9.7684 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 Bilirubin | Total 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 Bilirubin | Total bilirubin, at Day 14 | 0.6199 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 Bilirubin | Total 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 Bilirubin | Glucose, 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 Bilirubin | Blood urea nitrogen, at Baseline | 3.83775 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 Bilirubin | Blood urea nitrogen, at Day 2 | 1.21380 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 Bilirubin | Blood urea nitrogen, at Day 7 | 0.30345 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 Bilirubin | Blood urea nitrogen, at Week 16 | 0.21420 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 Bilirubin | Blood urea nitrogen, at Week 24 | 0.32576 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 Bilirubin | Creatinine, at Week 4 | 2.9835 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 Bilirubin | Direct Bilirubin, at Day 7 | 0.0000 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 Bilirubin | Total bilirubin, at Day 7 | 1.6031 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 Bilirubin | Total 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 Bilirubin | Total bilirubin, at Week 24 | 0.0428 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 Bilirubin | Total bilirubin, at Day 4 | 0.0570 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 Bilirubin | Blood urea nitrogen, at Day 7 | 0.58459 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 Bilirubin | Creatinine, 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 Bilirubin | Total 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 Bilirubin | Direct Bilirubin, at Baseline | 1.7741 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 Bilirubin | Blood 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Direct Bilirubin, at Day 4 | 0.0285 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 Bilirubin | Direct Bilirubin, at Day 7 | 0.0214 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 Bilirubin | Direct Bilirubin, at Day 8 | 0.1995 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Direct Bilirubin, at Week 4 | 0.0000 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 Bilirubin | Creatinine, at Day 14 | 0.6630 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 Bilirubin | Direct 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 Bilirubin | Direct 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 Bilirubin | Total bilirubin, at Day 8 | 0.9405 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 Bilirubin | Total bilirubin, at Baseline | 10.4738 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 Bilirubin | Total 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 Bilirubin | Total 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 Bilirubin | Total 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 Bilirubin | Total 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 Bilirubin | Total 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 Bilirubin | Total 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 Bilirubin | Glucose, at Day 14 | 0.048571 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 Bilirubin | Glucose, at Week 16 | 0.076326 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 Bilirubin | Glucose, 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 Bilirubin | Glucose, at Baseline | 5.037533 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 Bilirubin | Glucose, at Day 2 | 0.256734 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 Bilirubin | Glucose, 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 Bilirubin | Glucose, 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 Bilirubin | Creatinine, 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 Bilirubin | Glucose, at Day 7 | 0.548161 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 Bilirubin | Glucose, 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 Bilirubin | Glucose, at Day 10 | 0.000000 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 Bilirubin | Blood urea nitrogen, at Baseline | 4.19475 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 Bilirubin | Glucose, 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 Bilirubin | Blood urea nitrogen, at Day 8 | 0.55930 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 Bilirubin | Blood urea nitrogen, at Day 10 | 0.35700 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 Bilirubin | Blood urea nitrogen, at Day 2 | 0.39270 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 Bilirubin | Blood 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 Bilirubin | Blood 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 Bilirubin | Blood urea nitrogen, at Week 24 | 0.26775 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 Bilirubin | Blood urea nitrogen, at Day 3 | 0.67830 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 Bilirubin | Creatinine, at Baseline | 68.0680 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 Bilirubin | Creatinine, 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 Bilirubin | Creatinine, 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 Bilirubin | Blood urea nitrogen, at Day 4 | 0.82705 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 Bilirubin | Creatinine, at Day 7 | 2.4310 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 Bilirubin | Creatinine, 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 Bilirubin | Creatinine, at Day 10 | 11.9340 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 Bilirubin | Creatinine, at Week 4 | 0.1105 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 Bilirubin | Total 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 Bilirubin | Creatinine, 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 Bilirubin | Creatinine, at Day 2 | 2.3205 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 Bilirubin | Total bilirubin, at Day 4 | 2.0306 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 Bilirubin | Creatinine, at Day 3 | 3.6465 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 Bilirubin | Glucose, at Day 3 | 0.201224 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 Bilirubin | Creatinine, at Day 4 | 0.8840 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 Bilirubin | Total bilirubin, at Baseline | 12.5258 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 Bilirubin | Total 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 Bilirubin | Creatinine, at Day 7 | 6.2985 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 Bilirubin | Blood 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 Bilirubin | Glucose, 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 Bilirubin | Blood urea nitrogen, at Day 4 | 0.15619 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 Bilirubin | Total bilirubin, at Day 2 | 0.6413 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 Bilirubin | Creatinine, at Week 4 | 2.7625 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 Bilirubin | Creatinine, at Baseline | 73.8140 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 Bilirubin | Total 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 Bilirubin | Creatinine, at Week 16 | 3.1571 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 Bilirubin | Blood 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 Bilirubin | Glucose, at Day 7 | 0.166530 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 Bilirubin | Creatinine, at Week 24 | 5.6829 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 Bilirubin | Total 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 Bilirubin | Blood urea nitrogen, at Day 3 | 0.16511 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 Bilirubin | Direct Bilirubin, at Baseline | 2.1161 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 Bilirubin | Total 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 Bilirubin | Blood 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 Bilirubin | Direct 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 Bilirubin | Glucose, at Day 14 | 0.006939 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 Bilirubin | Direct 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 Bilirubin | Blood 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 Bilirubin | Direct Bilirubin, at Day 4 | 0.1283 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 Bilirubin | Glucose, at Week 16 | 0.111020 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 Bilirubin | Direct 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 Bilirubin | Total bilirubin, at Day 3 | 0.4061 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 Bilirubin | Blood urea nitrogen, at Baseline | 4.73025 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 Bilirubin | Blood urea nitrogen, at Week 16 | 0.03060 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 Bilirubin | Blood urea nitrogen, at Day 2 | 0.27221 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 Bilirubin | Direct 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 Bilirubin | Total 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 Bilirubin | Glucose, at Baseline | 4.864064 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 Bilirubin | Direct 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 Bilirubin | Glucose, at Week 24 | 0.237900 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 Bilirubin | Glucose, at Week 4 | 0.215101 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 Bilirubin | Direct 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 Bilirubin | Creatinine, at Day 14 | 3.4255 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 Bilirubin | Glucose, at Day 2 | 0.145714 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 Bilirubin | Direct Bilirubin, at Week 24 | -0.3176 milligram per deciliter (mg/dL) | Standard Deviation 0.36178 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 14 | 0.0118 Proportion of red blood cells in blood | Standard Deviation 0.01426 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 7 | 0.0168 Proportion of red blood cells in blood | Standard Deviation 0.01662 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Baseline | 0.3873 Proportion of red blood cells in blood | Standard Deviation 0.04541 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 4 | 0.0016 Proportion of red blood cells in blood | Standard Deviation 0.01672 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 24 | 0.0119 Proportion of red blood cells in blood | Standard Deviation 0.01389 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 16 | 0.0196 Proportion of red blood cells in blood | Standard Deviation 0.02303 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 2 | 0.0159 Proportion of red blood cells in blood | Standard Deviation 0.02226 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 3 | 0.0100 Proportion of red blood cells in blood | Standard Deviation 0.02612 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 4 | 0.0003 Proportion of red blood cells in blood | Standard Deviation 0.01992 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 7 | 0.0043 Proportion of red blood cells in blood | Standard Deviation 0.01521 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 8 | 0.0062 Proportion of red blood cells in blood | Standard Deviation 0.01781 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 10 | -0.0270 Proportion of red blood cells in blood | Standard Deviation 0.01131 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 4 | -0.0013 Proportion of red blood cells in blood | Standard Deviation 0.01641 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 16 | 0.0078 Proportion of red blood cells in blood | Standard Deviation 0.02315 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Baseline | 0.3928 Proportion of red blood cells in blood | Standard Deviation 0.04415 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 2 | 0.0005 Proportion of red blood cells in blood | Standard Deviation 0.01513 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 14 | -0.0074 Proportion of red blood cells in blood | Standard Deviation 0.01736 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 24 | 0.0053 Proportion of red blood cells in blood | Standard Deviation 0.02437 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 7 | -0.0065 Proportion of red blood cells in blood | Standard Deviation 0.01208 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 3 | 0.0066 Proportion of red blood cells in blood | Standard Deviation 0.01502 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 2 | 0.0118 Proportion of red blood cells in blood | Standard Deviation 0.01704 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 4 | 0.0023 Proportion of red blood cells in blood | Standard Deviation 0.01646 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 4 | -0.0069 Proportion of red blood cells in blood | Standard Deviation 0.01605 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 24 | -0.0076 Proportion of red blood cells in blood | Standard Deviation 0.03243 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Day 14 | -0.0056 Proportion of red blood cells in blood | Standard Deviation 0.0142 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Week 16 | -0.0106 Proportion of red blood cells in blood | Standard Deviation 0.00759 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hematocrit | Baseline | 0.4253 Proportion of red blood cells in blood | Standard Deviation 0.04709 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Hemoglobin, Albumin and Total Protein | Albumin, at Day 2 | 0.4 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 Protein | Albumin, at Week 16 | 0.6 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 Protein | Hemoglobin, at Week 16 | 4.3 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 Protein | Hemoglobin, at Day 2 | 5.8 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 Protein | Hemoglobin, at Baseline | 131.4 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 Protein | Total Protein, at Day 14 | 0.0 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 Protein | Hemoglobin, at Day 14 | 3.4 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 Protein | Total 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 Protein | Albumin, at Day 7 | 0.1 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 Protein | Albumin, 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 Protein | Total Protein, at Week 16 | 0.9 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 Protein | Albumin, 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 Protein | Hemoglobin, at Week 4 | 1.0 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 Protein | Total 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 Protein | Total Protein, at Day 2 | 0.6 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 Protein | Total Protein, at Day 7 | 0.0 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 Protein | Hemoglobin, at Day 7 | 2.6 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 Protein | Albumin, at Day 14 | 0.0 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 Protein | Hemoglobin, at Week 24 | 0.4 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 Protein | Total Protein, at Baseline | 70.0 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 Protein | Albumin, at Baseline | 44.0 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 Protein | Hemoglobin, at Day 8 | 3.3 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 Protein | Hemoglobin, at Day 2 | 1.9 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 Protein | Hemoglobin, at Day 3 | 6.8 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 Protein | Hemoglobin, at Day 4 | 4.8 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 Protein | Hemoglobin, at Day 7 | 2.9 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 Protein | Hemoglobin, 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 Protein | Hemoglobin, 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 Protein | Hemoglobin, at Week 16 | 5.3 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 Protein | Hemoglobin, at Week 24 | 4.0 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 Protein | Albumin, 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 Protein | Albumin, 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 Protein | Albumin, 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 Protein | Total 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 Protein | Albumin, 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 Protein | Albumin, 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 Protein | Total Protein, at Baseline | 71.0 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 Protein | Total 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 Protein | Total Protein, at Day 8 | 2.76 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 Protein | Total 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 Protein | Total 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 Protein | Total Protein, at Week 16 | 1.0 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 Protein | Total Protein, at Week 24 | 0.1 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 Protein | Hemoglobin, at Baseline | 128.3 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 Protein | Hemoglobin, at Week 4 | 0.4 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 Protein | Albumin, at Baseline | 43.9 Grams per liter (g/L) | Standard Deviation 3 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hemoglobin, Albumin and Total Protein | Albumin, 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 Protein | Albumin, 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 Protein | Albumin, 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 Protein | Albumin, at Week 16 | 0.8 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 Protein | Albumin, 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 Protein | Total Protein, at Day 3 | 1.3 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 Protein | Total Protein, at Day 4 | 0.0 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 Protein | Total 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 Protein | Hemoglobin, at Baseline | 142.4 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 Protein | Hemoglobin, at Day 4 | 3.9 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 Protein | Hemoglobin, 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 Protein | Albumin, 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 Protein | Hemoglobin, 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 Protein | Hemoglobin, at Day 2 | 3.9 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 Protein | Albumin, at Baseline | 43.9 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 Protein | Albumin, 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 Protein | Hemoglobin, 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 Protein | Hemoglobin, at Day 3 | 4.3 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 Protein | Total 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 Protein | Albumin, 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 Protein | Total 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 Protein | Hemoglobin, 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 Protein | Total Protein, at Day 4 | 0.6 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 Protein | Total 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 Protein | Total Protein, at Baseline | 72.3 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 Protein | Albumin, 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 Protein | Total 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 Protein | Albumin, at Day 7 | 0.4 Grams per liter (g/L) | Standard Deviation 2 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Hemoglobin, Albumin and Total Protein | Hemoglobin, 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 Protein | Total 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 Protein | Albumin, at Day 4 | 0.3 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 Protein | Total 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 Protein | Total 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 Protein | Albumin, 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 Protein | Albumin, at Week 16 | -2.0 Grams per liter (g/L) | Standard Deviation 2.16 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline | 29.05 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 2 | 0.20 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 24 | 0.39 picograms (pg) | Standard Deviation 0.716 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline | 28.33 picograms (pg) | Standard Deviation 2.213 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 2 | 0.21 picograms (pg) | Standard Deviation 0.458 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 3 | 0.63 picograms (pg) | Standard Deviation 0.836 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 4 | 0.67 picograms (pg) | Standard Deviation 0.463 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 7 | 0.16 picograms (pg) | Standard Deviation 0.385 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 8 | 0.27 picograms (pg) | Standard Deviation 0.48 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 14 | 0.44 picograms (pg) | Standard Deviation 0.524 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4 | 0.39 picograms (pg) | Standard Deviation 0.617 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 16 | 0.39 picograms (pg) | Standard Deviation 0.779 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 4 | 0.55 picograms (pg) | Standard Deviation 0.678 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 24 | 0.31 picograms (pg) | Standard Deviation 1.524 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4 | 0.16 picograms (pg) | Standard Deviation 0.466 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 3 | 0.39 picograms (pg) | Standard Deviation 0.29 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline | 29.26 picograms (pg) | Standard Deviation 1.66 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 16 | 0.24 picograms (pg) | Standard Deviation 0.737 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Day 7 | 0.29 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 14 | 0.33 picograms (pg) | Standard Deviation 0.59 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline | 85.78 cubic microns | Standard Deviation 2.013 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 2 | 0.14 cubic microns | Standard Deviation 0.466 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 7 | 0.84 cubic microns | Standard Deviation 0.661 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 14 | 0.06 cubic microns | Standard 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 microns | Standard Deviation 1.216 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 16 | 0.76 cubic microns | Standard Deviation 0.842 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 24 | 1.34 cubic microns | Standard Deviation 1.983 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 16 | -0.75 cubic microns | Standard Deviation 2.522 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4 | 0.34 cubic microns | Standard Deviation 1.125 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 8 | -0.27 cubic microns | Standard Deviation 0.674 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline | 86.89 cubic microns | Standard Deviation 6.081 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 10 | 0.05 cubic microns | Standard Deviation 0.354 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 24 | -0.41 cubic microns | Standard Deviation 2.107 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 2 | -0.66 cubic microns | Standard Deviation 0.478 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 7 | -0.61 cubic microns | Standard Deviation 0.562 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 3 | -0.72 cubic microns | Standard Deviation 0.492 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 14 | 0.04 cubic microns | Standard Deviation 0.746 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 4 | -1.38 cubic microns | Standard Deviation 0.542 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 14 | 0.06 cubic microns | Standard Deviation 0.623 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 4 | -0.41 cubic microns | Standard Deviation 0.589 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4 | -0.03 cubic microns | Standard Deviation 0.703 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 7 | -0.10 cubic microns | Standard Deviation 0.469 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 16 | 0.74 cubic microns | Standard Deviation 1.078 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 3 | -0.03 cubic microns | Standard Deviation 0.345 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 24 | 0.40 cubic microns | Standard Deviation 2.195 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline | 87.28 cubic microns | Standard Deviation 3.478 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Mean Corpuscle Volume (MCV) | Day 2 | -0.03 cubic microns | Standard Deviation 0.354 |
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.
| Arm | Measure | Group | Value (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 Basophils | Neutrophils, at Day 14 | -0.340 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 14 | -0.019 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 2 | 0.315 10^9 cells/L | Standard 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 Basophils | WBC, at Day 7 | 0.11 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 14 | 0.059 10^9 cells/L | Standard 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 Basophils | Basophils, at Baseline | 0.033 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 7 | 1.4 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 4 | -0.160 10^9 cells/L | Standard 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 Basophils | WBC, at Day 14 | -0.26 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 4 | 0.036 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 2 | 0.091 10^9 cells/L | Standard 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 Basophils | WBC, at Week 4 | -0.03 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 16 | -0.178 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 14 | 19.9 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 2 | -0.004 10^9 cells/L | Standard 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 Basophils | WBC, at Week 24 | -0.46 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 2 | 0.018 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 7 | 0.066 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Baseline | 1.368 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 4 | 30.6 10^9 cells/L | Standard 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 Basophils | WBC, at Week 16 | 0.01 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 2 | 0.006 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Baseline | 0.121 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 24 | 1.1 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 24 | -0.535 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 24 | -0.018 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 4 | 0.045 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 14 | 0.034 10^9 cells/L | Standard 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 Basophils | Platelets, at Baseline | 256.3 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 16 | 0.059 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 16 | -0.001 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 4 | 0.063 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 24 | 0.000 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 7 | 0.008 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 16 | 0.100 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 24 | 0.001 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 7 | 0.016 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 24 | 0.058 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 2 | 6.6 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 14 | 0.001 10^9 cells/L | Standard 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 Basophils | Monocytes, at Baseline | 0.396 10^9 cells/L | Standard 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 Basophils | WBC, at Baseline | 5.13 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Baseline | 3.218 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 7 | -0.043 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 16 | -0.5 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 4 | 0.003 10^9 cells/L | Standard 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 Basophils | WBC, at Day 2 | 0.43 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 16 | 0.023 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 7 | 0.049 10^9 cells/L | Standard 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 Basophils | WBC, at Day 7 | -0.04 10^9 cells/L | Standard 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 Basophils | WBC, at Day 8 | -0.05 10^9 cells/L | Standard 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 Basophils | WBC, at Day 10 | -0.85 10^9 cells/L | Standard 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 Basophils | WBC, at Day 14 | -0.38 10^9 cells/L | Standard 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 Basophils | Basophils, at Baseline | 0.035 10^9 cells/L | Standard 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 Basophils | WBC, at Week 4 | -0.40 10^9 cells/L | Standard 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 Basophils | WBC, at Day 4 | 0.32 10^9 cells/L | Standard 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 Basophils | WBC, at Week 24 | 0.40 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 2 | 0.000 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Baseline | 2.214 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 2 | -0.484 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 3 | 0.005 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 3 | -0.175 10^9 cells/L | Standard 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 Basophils | WBC, at Week 16 | -0.63 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 4 | -0.065 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 4 | 0.012 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 8 | -0.193 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 10 | -0.475 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 8 | 0.002 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 4 | -0.314 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 16 | -0.190 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 10 | 0.000 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 24 | -0.380 10^9 cells/L | Standard 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 Basophils | Monocytes, at Baseline | 0.461 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 14 | 0.008 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 3 | 0.040 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 4 | 0.080 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 4 | 0.004 10^9 cells/L | Standard 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 Basophils | WBC, at Day 3 | 0.13 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 7 | -0.211 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 8 | 0.008 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 10 | -0.110 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 14 | -0.078 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 4 | -0.045 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 16 | 0.004 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 16 | -0.029 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 24 | 0.001 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Baseline | 0.098 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Baseline | 3.499 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 2 | 0.214 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 3 | 0.238 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 2 | 0.010 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 4 | 0.262 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 14 | -0.386 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 8 | 0.160 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 10 | -0.270 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 14 | 0.096 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 3 | 0.017 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 4 | -0.036 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 16 | -0.468 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 4 | 0.022 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 24 | 0.691 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 2 | -0.048 10^9 cells/L | Standard 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 Basophils | Platelets, at Baseline | 301.9 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 2 | -14.6 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 7 | 0.000 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 3 | 3.2 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 10 | -0.010 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 4 | -4.2 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 7 | 0.0 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 14 | 0.011 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 8 | 2.8 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 10 | -8.0 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 14 | 1.0 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 4 | -3.5 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 24 | 12.5 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 7 | 0.003 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 4 | 0.001 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 7 | 0.210 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 16 | 0.053 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 24 | 0.094 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 8 | 0.003 10^9 cells/L | Standard 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 Basophils | WBC, at Baseline | 6.31 10^9 cells/L | Standard 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 Basophils | WBC, at Day 2 | -0.31 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 16 | 6.6 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 7 | -0.021 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 24 | 0.001 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 24 | -2.3 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 7 | -0.005 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 16 | -0.001 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 24 | -0.013 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 7 | 0.016 10^9 cells/L | Standard 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 Basophils | WBC, at Day 3 | -0.41 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 4 | -0.106 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 7 | -0.079 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 4 | 3.1 10^9 cells/L | Standard 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 Basophils | Platelets, at Week 16 | -6.4 10^9 cells/L | Standard 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 Basophils | Basophils, at Baseline | 0.044 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 2 | -0.009 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 3 | -0.009 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 4 | -0.001 10^9 cells/L | Standard 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 Basophils | Basophils, at Day 14 | 0.003 10^9 cells/L | Standard 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 Basophils | Basophils, at Week 4 | 0.000 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Baseline | 0.145 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 2 | 0.016 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 3 | 0.010 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 4 | 0.010 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Day 14 | 0.025 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 4 | -0.004 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 16 | 0.013 10^9 cells/L | Standard 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 Basophils | Eosinophils, at Week 24 | -0.001 10^9 cells/L | Standard 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 Basophils | WBC, at Baseline | 6.50 10^9 cells/L | Standard 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 Basophils | WBC, at Day 2 | -0.36 10^9 cells/L | Standard 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 Basophils | WBC, at Day 4 | -0.49 10^9 cells/L | Standard 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 Basophils | WBC, at Day 7 | -0.25 10^9 cells/L | Standard 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 Basophils | WBC, at Day 14 | -0.25 10^9 cells/L | Standard 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 Basophils | WBC, at Week 4 | -0.48 10^9 cells/L | Standard 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 Basophils | WBC, at Week 16 | -0.64 10^9 cells/L | Standard 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 Basophils | WBC, at Week 24 | -0.51 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Baseline | 2.086 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 2 | -0.094 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 3 | -0.135 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 7 | -0.175 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Day 14 | -0.161 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 4 | -0.226 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 16 | -0.191 10^9 cells/L | Standard 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 Basophils | Lymphocytes, at Week 24 | -0.339 10^9 cells/L | Standard 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 Basophils | Monocytes, at Baseline | 0.485 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 2 | -0.008 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 3 | -0.013 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 4 | -0.006 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 7 | -0.013 10^9 cells/L | Standard 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 Basophils | Monocytes, at Day 14 | -0.015 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 4 | -0.034 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 16 | 0.001 10^9 cells/L | Standard 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 Basophils | Monocytes, at Week 24 | -0.020 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Baseline | 3.756 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 2 | -0.263 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 3 | -0.291 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 4 | -0.398 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Day 14 | -0.116 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 4 | -0.233 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 16 | -0.500 10^9 cells/L | Standard 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 Basophils | Neutrophils, at Week 24 | -0.160 10^9 cells/L | Standard 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 Basophils | Platelets, at Baseline | 289.5 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 2 | 1.0 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 3 | 0.1 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 4 | -4.9 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 7 | 1.9 10^9 cells/L | Standard 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 Basophils | Platelets, at Day 14 | 2.1 10^9 cells/L | Standard Deviation 40.86 |
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.
| Arm | Measure | Group | Value (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 Miliseconds | Standard 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 4 | 9.542 Miliseconds | Standard 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 1 | 2.833 Miliseconds | Standard 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 1 | 0.708 Miliseconds | Standard 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 24 | 4.583 Miliseconds | Standard 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 7 | 8.667 Miliseconds | Standard 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 Baseline | 378.875 Miliseconds | Standard 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 Baseline | 92.875 Miliseconds | Standard 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 4 | 1.167 Miliseconds | Standard 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 4 | 0.708 Miliseconds | Standard 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 1 | 0.875 Miliseconds | Standard 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 7 | 0.000 Miliseconds | Standard 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 Miliseconds | Standard 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 2 | 4.750 Miliseconds | Standard 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 4 | 1.458 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 161.375 Miliseconds | Standard 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 24 | 2.417 Miliseconds | Standard 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 Baseline | 402.750 Miliseconds | Standard 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 Miliseconds | Standard 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 4 | 14.083 Miliseconds | Standard 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 Miliseconds | Standard 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 3 | 1.083 Miliseconds | Standard 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 Miliseconds | Standard 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 7 | 7.042 Miliseconds | Standard 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 4 | 4.625 Miliseconds | Standard 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 24 | 15.125 Miliseconds | Standard 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 4 | 5.917 Miliseconds | Standard 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 7 | 1.458 Miliseconds | Standard 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 Miliseconds | Standard 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 3 | 8.583 Miliseconds | Standard 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 3 | 0.917 Miliseconds | Standard 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 7 | 21.083 Miliseconds | Standard 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 2 | 1.917 Miliseconds | Standard 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 2 | 20.750 Miliseconds | Standard 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 24 | 13.167 Miliseconds | Standard 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 Miliseconds | Standard 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 4 | 6.500 Miliseconds | Standard 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 Baseline | 164.000 Miliseconds | Standard 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 3 | 3.000 Miliseconds | Standard 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 4 | 0.875 Miliseconds | Standard 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 7 | 6.167 Miliseconds | Standard 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 8 | 5.875 Miliseconds | Standard 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 10 | 19.167 Miliseconds | Standard 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 4 | 4.250 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 90.750 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 395.875 Miliseconds | Standard 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 3 | 10.542 Miliseconds | Standard 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 4 | 7.000 Miliseconds | Standard 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 8 | 19.167 Miliseconds | Standard 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 10 | 31.667 Miliseconds | Standard 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 4 | 31.167 Miliseconds | Standard 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 Baseline | 419.375 Miliseconds | Standard 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 2 | 1.083 Miliseconds | Standard 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 Miliseconds | Standard 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 7 | 0.958 Miliseconds | Standard 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 8 | 1.833 Miliseconds | Standard 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 10 | 0.667 Miliseconds | Standard 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 24 | 2.229 Miliseconds | Standard 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 7 | 2.625 Miliseconds | Standard 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 2 | 3.375 Miliseconds | Standard 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 3 | 9.792 Miliseconds | Standard 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 4 | 3.000 Miliseconds | Standard 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 3 | 2.083 Miliseconds | Standard 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 4 | 9.167 Miliseconds | Standard 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 3 | 3.667 Miliseconds | Standard 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 2 | 3.500 Miliseconds | Standard 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 7 | 8.500 Miliseconds | Standard 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 24 | 15.952 Miliseconds | Standard 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 24 | 7.238 Miliseconds | Standard 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 1 | 0.500 Miliseconds | Standard 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 4 | 2.250 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 164.875 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 7 | 3.500 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 397.000 Miliseconds | Standard 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 4 | 1.917 Miliseconds | Standard 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 Baseline | 100.250 Miliseconds | Standard 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 1 | 1.375 Miliseconds | Standard 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 4 | 10.583 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 Baseline | 380.375 Miliseconds | Standard 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 Miliseconds | Standard 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 Miliseconds | Standard 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 2 | 16.083 Miliseconds | Standard Deviation 13.6449 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Pulse Rate | Week 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 Rate | Week 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 Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Baseline | 73.9 Beats per minute (Beats/min) | Standard Deviation 7.85 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Pulse Rate | Week 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 Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Baseline | 71.1 Beats per minute (Beats/min) | Standard Deviation 7.16 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Pulse Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Week 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 Rate | Day 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Day 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 Rate | Week 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 Rate | Week 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 Rate | Day 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 Rate | Baseline | 75.9 Beats per minute (Beats/min) | Standard Deviation 12.26 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Pulse Rate | Week 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Week 24 | -15.3 Beats per minute (Beats/min) | Standard Deviation 11.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Red Blood Cell Count (RBC) | Baseline | 4.518 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 7 | 0.155 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 14 | 0.130 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 2 | 0.180 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 16 | 0.186 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 4 | 0.050 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 24 | 0.063 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 3 | 0.163 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 4 | 0.085 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 7 | 0.084 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 8 | 0.088 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 24 | 0.078 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) | Baseline | 4.523 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 2 | 0.043 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 16 | 0.124 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 3 | 0.079 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 4 | 0.056 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 2 | 0.141 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) | Baseline | 4.889 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 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 4 | 1.3 Breaths per minute (Breaths/min) | Standard Deviation 2.38 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Day 7 | 0.8 Breaths per minute (Breaths/min) | Standard Deviation 4.77 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Week 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 Rate | Day 1/8 Hours Postdose | 1.5 Breaths per minute (Breaths/min) | Standard Deviation 2.56 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Baseline | 15.5 Breaths per minute (Breaths/min) | Standard Deviation 1.41 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 8 | 1.0 Breaths per minute (Breaths/min) | Standard Deviation 2.83 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Week 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 Rate | Day 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 Rate | Day 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 Rate | Baseline | 15.8 Breaths per minute (Breaths/min) | Standard Deviation 3.77 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 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 Rate | Day 10 | 0.0 Breaths per minute (Breaths/min) | Standard Deviation 5.66 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Day 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Week 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 Rate | Week 16 | 3.1 Breaths per minute (Breaths/min) | Standard Deviation 1.95 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 4 | 1.0 Breaths per minute (Breaths/min) | Standard Deviation 2.83 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 1/8 Hours Postdose | 0.8 Breaths per minute (Breaths/min) | Standard Deviation 3.85 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 24 | 0.3 Breaths per minute (Breaths/min) | Standard Deviation 2.93 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 8 | 1.3 Breaths per minute (Breaths/min) | Standard Deviation 1.83 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 1/4 Hours Postdose | 2.0 Breaths per minute (Breaths/min) | Standard Deviation 3.38 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Week 20 | 1.1 Breaths per minute (Breaths/min) | Standard Deviation 3.98 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 4 | 0.0 Breaths per minute (Breaths/min) | Standard Deviation 2.62 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Week 12 | 1.5 Breaths per minute (Breaths/min) | Standard Deviation 2.33 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 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 Rate | Day 3 | 2.3 Breaths per minute (Breaths/min) | Standard Deviation 2.71 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Baseline | 13.8 Breaths per minute (Breaths/min) | Standard Deviation 1.98 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 21 | 1.0 Breaths per minute (Breaths/min) | Standard Deviation 3.85 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Respiratory Rate | Day 2 | 1.3 Breaths per minute (Breaths/min) | Standard Deviation 2.12 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 2 | -0.6 Millimole per liter (mmol/L) | Standard Deviation 2.45 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 24 | -0.1 Millimole per liter (mmol/L) | Standard Deviation 2.36 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 2 | -0.015594 Millimole per liter (mmol/L) | Standard Deviation 0.1041067 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 14 | 0.009356 Millimole per liter (mmol/L) | Standard Deviation 0.0398698 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 16 | -0.4 Millimole per liter (mmol/L) | Standard Deviation 2.13 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 7 | -0.5 Millimole per liter (mmol/L) | Standard Deviation 1.07 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 4 | -1.3 Millimole per liter (mmol/L) | Standard Deviation 2.38 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 16 | -0.8 Millimole per liter (mmol/L) | Standard Deviation 1.58 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 14 | -1.6 Millimole per liter (mmol/L) | Standard Deviation 1.77 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 7 | -0.012475 Millimole per liter (mmol/L) | Standard Deviation 0.0533453 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 2 | 0.09 Millimole per liter (mmol/L) | Standard Deviation 0.242 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 16 | -0.015594 Millimole per liter (mmol/L) | Standard Deviation 0.0842805 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Baseline | 103.1 Millimole per liter (mmol/L) | Standard Deviation 1.81 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 24 | -0.056138 Millimole per liter (mmol/L) | Standard Deviation 0.0861717 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 7 | -0.5 Millimole per liter (mmol/L) | Standard Deviation 1.77 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 24 | -0.5 Millimole per liter (mmol/L) | Standard Deviation 1.2 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Baseline | 29.4 Millimole per liter (mmol/L) | Standard Deviation 1.77 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 24 | -1.1 Millimole per liter (mmol/L) | Standard Deviation 2.53 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 16 | -1.3 Millimole per liter (mmol/L) | Standard Deviation 1.28 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 2 | 0.5 Millimole per liter (mmol/L) | Standard Deviation 1.41 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 2 | -0.4 Millimole per liter (mmol/L) | Standard Deviation 2.13 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 4 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 1.51 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 4 | -0.9 Millimole per liter (mmol/L) | Standard Deviation 2.17 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 7 | -0.3 Millimole per liter (mmol/L) | Standard Deviation 1.39 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Baseline | 138.8 Millimole per liter (mmol/L) | Standard Deviation 1.39 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 16 | -0.38 Millimole per liter (mmol/L) | Standard Deviation 0.413 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 4 | -0.031188 Millimole per liter (mmol/L) | Standard Deviation 0.0739536 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 4 | -0.16 Millimole per liter (mmol/L) | Standard Deviation 0.389 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 24 | -0.06 Millimole per liter (mmol/L) | Standard Deviation 0.245 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 14 | 0.3 Millimole per liter (mmol/L) | Standard Deviation 0.89 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 14 | -0.13 Millimole per liter (mmol/L) | Standard Deviation 0.381 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 14 | -1.3 Millimole per liter (mmol/L) | Standard Deviation 1.39 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 7 | -0.30 Millimole per liter (mmol/L) | Standard Deviation 0.421 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Baseline | 4.36 Millimole per liter (mmol/L) | Standard Deviation 0.484 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Baseline | 2.329706 Millimole per liter (mmol/L) | Standard Deviation 0.1049575 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 14 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 2.88 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 8 | -0.004158 Millimole per liter (mmol/L) | Standard Deviation 0.0639356 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 10 | -0.112275 Millimole per liter (mmol/L) | Standard Deviation 0.0882116 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 14 | -0.034306 Millimole per liter (mmol/L) | Standard Deviation 0.0923367 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 4 | -0.034306 Millimole per liter (mmol/L) | Standard Deviation 0.0853291 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 7 | 0.3 Millimole per liter (mmol/L) | Standard Deviation 1.28 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 10 | 0.0 Millimole per liter (mmol/L) | Standard Deviation 1.41 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 2 | 0.0 Millimole per liter (mmol/L) | Standard Deviation 2 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 7 | 0.1 Millimole per liter (mmol/L) | Standard Deviation 1.64 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 2 | 0.16 Millimole per liter (mmol/L) | Standard Deviation 0.325 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 4 | 0.00 Millimole per liter (mmol/L) | Standard Deviation 0.544 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 4 | 0.18 Millimole per liter (mmol/L) | Standard Deviation 0.183 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 16 | 0.11 Millimole per liter (mmol/L) | Standard Deviation 0.189 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 2 | -0.4 Millimole per liter (mmol/L) | Standard Deviation 2.26 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Baseline | 2.317231 Millimole per liter (mmol/L) | Standard Deviation 0.0805028 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 2 | -0.003119 Millimole per liter (mmol/L) | Standard Deviation 0.0983979 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 3 | 0.037425 Millimole per liter (mmol/L) | Standard Deviation 0.1101762 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 4 | 0.008317 Millimole per liter (mmol/L) | Standard Deviation 0.1145166 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Day 7 | -0.006238 Millimole per liter (mmol/L) | Standard Deviation 0.083018 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 16 | 0.018713 Millimole per liter (mmol/L) | Standard Deviation 0.0751464 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Calcium, at Week 24 | -0.031188 Millimole per liter (mmol/L) | Standard Deviation 0.0371268 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Baseline | 27.8 Millimole per liter (mmol/L) | Standard Deviation 2.25 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 2 | 0.6 Millimole per liter (mmol/L) | Standard Deviation 1.19 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 3 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 0.84 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 4 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 1.03 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 8 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 1.03 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Day 14 | 0.5 Millimole per liter (mmol/L) | Standard Deviation 1.51 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 4 | 0.9 Millimole per liter (mmol/L) | Standard Deviation 1.64 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 16 | 0.3 Millimole per liter (mmol/L) | Standard Deviation 0.71 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Carbon Dioxide, at Week 24 | 0.4 Millimole per liter (mmol/L) | Standard Deviation 1.51 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Baseline | 102.1 Millimole per liter (mmol/L) | Standard Deviation 2.59 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 3 | -1.2 Millimole per liter (mmol/L) | Standard Deviation 1.94 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 4 | -1.5 Millimole per liter (mmol/L) | Standard Deviation 1.64 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 8 | 0.3 Millimole per liter (mmol/L) | Standard Deviation 1.75 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 10 | 5.5 Millimole per liter (mmol/L) | Standard Deviation 2.12 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Day 14 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 2.56 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 4 | 1.1 Millimole per liter (mmol/L) | Standard Deviation 2.47 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 16 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 1.41 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 24 | 0.6 Millimole per liter (mmol/L) | Standard Deviation 2.26 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Baseline | 4.14 Millimole per liter (mmol/L) | Standard Deviation 0.342 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 3 | 0.13 Millimole per liter (mmol/L) | Standard Deviation 0.372 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 7 | 0.29 Millimole per liter (mmol/L) | Standard Deviation 0.47 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 8 | 0.07 Millimole per liter (mmol/L) | Standard Deviation 0.207 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 10 | 0.45 Millimole per liter (mmol/L) | Standard Deviation 0.354 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Day 14 | 0.04 Millimole per liter (mmol/L) | Standard Deviation 0.513 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Potassium, at Week 24 | -0.03 Millimole per liter (mmol/L) | Standard Deviation 0.354 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Baseline | 137.1 Millimole per liter (mmol/L) | Standard Deviation 2.23 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 3 | -0.8 Millimole per liter (mmol/L) | Standard Deviation 0.98 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 4 | -1.3 Millimole per liter (mmol/L) | Standard Deviation 2.25 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 7 | 0.5 Millimole per liter (mmol/L) | Standard Deviation 2.2 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 8 | 0.3 Millimole per liter (mmol/L) | Standard Deviation 1.51 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Day 10 | 4.5 Millimole per liter (mmol/L) | Standard Deviation 4.95 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 4 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 2.45 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 16 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 2.51 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Sodium, at Week 24 | 0.1 Millimole per liter (mmol/L) | Standard Deviation 3.48 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide | Chloride, at Week 4 | 0.4 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 Dioxide | Calcium, 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 Dioxide | Calcium, 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 Dioxide | Chloride, at Week 16 | 0.7 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 Dioxide | Calcium, at Baseline | 2.351538 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 Dioxide | Sodium, 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 Dioxide | Chloride, at Week 24 | 1.7 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 Dioxide | Sodium, at Day 14 | 0.6 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 Dioxide | Sodium, at Week 4 | 0.9 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 Dioxide | Potassium, at Baseline | 4.29 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 Dioxide | Sodium, 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 Dioxide | Potassium, at Day 3 | 0.14 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 Dioxide | Calcium, at Day 7 | 0.037425 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 Dioxide | Potassium, at Day 2 | 0.10 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 Dioxide | Potassium, 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 Dioxide | Carbon Dioxide, at Day 4 | 0.3 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 Dioxide | Carbon 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 Dioxide | Calcium, at Week 4 | 0.003119 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 Dioxide | Sodium, at Day 7 | 0.8 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 Dioxide | Carbon 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 Dioxide | Carbon Dioxide, at Day 2 | 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 Dioxide | Sodium, at Day 2 | 0.1 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 Dioxide | Carbon Dioxide, at Week 4 | 0.0 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 Dioxide | Carbon Dioxide, at Baseline | 28.6 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 Dioxide | Sodium, at Week 24 | 2.0 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 Dioxide | Carbon 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 Dioxide | Calcium, 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 Dioxide | Potassium, at Day 14 | 0.09 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 Dioxide | Carbon Dioxide, at Week 24 | 0.3 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 Dioxide | Calcium, 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 Dioxide | Potassium, 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 Dioxide | Chloride, at Baseline | 102.4 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 Dioxide | Chloride, at Day 2 | 0.1 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 Dioxide | Sodium, at Week 16 | 1.3 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 Dioxide | Chloride, 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 Dioxide | Potassium, at Week 24 | 0.01 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 Dioxide | Chloride, 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 Dioxide | Chloride, at Day 7 | 0.5 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 Dioxide | Potassium, 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 Dioxide | Carbon Dioxide, at Day 7 | 0.3 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 Dioxide | Calcium, at Day 4 | 0.040544 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 Dioxide | Sodium, at Baseline | 136.9 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 Dioxide | Chloride, at Day 14 | 0.4 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 Dioxide | Calcium, at Day 3 | 0.003119 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 Dioxide | Potassium, at Day 4 | 0.13 Millimole per liter (mmol/L) | Standard Deviation 0.32 |
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.
| Arm | Measure | Group | Value (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 16 | 3.8 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 14 | 1.6 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 8 | 9.0 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 7 | 1.9 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 24 | 1.5 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 4 | 0.6 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 16 | 4.6 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 12 | 0.5 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 7 | 2.1 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 Baseline | 66.5 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 24 | 2.0 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 8 | 6.4 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 Baseline | 112.8 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 14 | 2.4 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 4 | 2.1 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 21 | 5.4 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 3 | 2.4 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 21 | 2.8 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 12 | 6.8 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 Baseline | 106.3 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 2 | 3.5 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 3 | 0.8 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 4 | 0.3 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 7 | 2.1 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 10 | 4.5 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 14 | 11.3 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 21 | 9.8 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 4 | 9.5 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 8 | 9.5 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 12 | 4.5 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 16 | 7.9 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 20 | 2.1 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 24 | 6.4 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 Baseline | 59.8 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 2 | 3.4 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 3 | 1.1 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 10 | 9.0 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 14 | 6.1 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 21 | 10.6 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 4 | 8.1 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 8 | 9.1 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 16 | 9.1 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 20 | 6.3 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 24 | 7.4 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 Baseline | 114.4 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 4 | 2.8 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 16 | 8.4 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 14 | 6.1 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 21 | 7.8 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 21 | 12.9 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 14 | 6.5 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 24 | 12.1 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 4 | 7.6 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 7 | 3.6 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 20 | 6.3 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 20 | 13.6 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 Baseline | 62.1 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 8 | 7.6 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 12 | 7.9 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 8 | 5.6 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 12 | 11.5 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 7 | 9.5 Millimeters of mercury (mmHg) | Standard Deviation 9.78 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 7 | -0.05 Degrees Celcius | Standard Deviation 0.524 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 3 | -0.23 Degrees Celcius | Standard Deviation 0.365 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 4 | -0.21 Degrees Celcius | Standard Deviation 0.364 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 12 | -0.23 Degrees Celcius | Standard Deviation 0.271 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 8 | -0.28 Degrees Celcius | Standard Deviation 0.399 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 20 | -0.17 Degrees Celcius | Standard Deviation 0.315 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Baseline | 36.54 Degrees Celcius | Standard Deviation 0.233 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 14 | -0.13 Degrees Celcius | Standard Deviation 0.392 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 24 | -0.19 Degrees Celcius | Standard Deviation 0.364 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 21 | -0.11 Degrees Celcius | Standard Deviation 0.554 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 16 | -0.34 Degrees Celcius | Standard Deviation 0.346 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 2 | -0.10 Degrees Celcius | Standard Deviation 0.424 |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 4 | -0.03 Degrees Celcius | Standard Deviation 0.311 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 12 | -0.33 Degrees Celcius | Standard Deviation 0.607 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 7 | -0.41 Degrees Celcius | Standard Deviation 0.622 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 4 | -0.56 Degrees Celcius | Standard Deviation 0.534 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 4 | -0.41 Degrees Celcius | Standard Deviation 0.569 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Baseline | 36.79 Degrees Celcius | Standard Deviation 0.344 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 2 | -0.48 Degrees Celcius | Standard Deviation 0.437 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 3 | -0.50 Degrees Celcius | Standard Deviation 0.475 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 8 | -0.41 Degrees Celcius | Standard Deviation 0.599 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 10 | -0.60 Degrees Celcius | Standard Deviation 0.566 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 14 | -0.28 Degrees Celcius | Standard Deviation 0.492 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 21 | -0.49 Degrees Celcius | Standard Deviation 0.352 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 8 | -0.45 Degrees Celcius | Standard Deviation 0.535 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 16 | -0.33 Degrees Celcius | Standard Deviation 0.575 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 20 | -0.40 Degrees Celcius | Standard Deviation 0.414 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 24 | -0.55 Degrees Celcius | Standard Deviation 0.678 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 8 | -0.20 Degrees Celcius | Standard Deviation 0.566 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 4 | -0.20 Degrees Celcius | Standard Deviation 0.463 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 2 | -0.14 Degrees Celcius | Standard Deviation 0.342 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 12 | -0.28 Degrees Celcius | Standard Deviation 0.423 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Baseline | 36.49 Degrees Celcius | Standard Deviation 0.5 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 4 | -0.09 Degrees Celcius | Standard Deviation 0.549 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 16 | -0.69 Degrees Celcius | Standard Deviation 0.534 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 3 | -0.25 Degrees Celcius | Standard Deviation 0.454 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 14 | -0.28 Degrees Celcius | Standard Deviation 0.453 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 24 | 0.09 Degrees Celcius | Standard Deviation 0.367 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 21 | -0.04 Degrees Celcius | Standard Deviation 0.469 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Day 7 | -0.04 Degrees Celcius | Standard Deviation 0.578 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Change From Baseline in Temperature | Week 20 | -0.19 Degrees Celcius | Standard Deviation 0.505 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Maximum Observed Concentration (Cmax) of VH3810109 | 148.2 μg/mL |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Maximum Observed Concentration (Cmax) of VH3810109 | 1864 μg/mL |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Maximum Observed Concentration (Cmax) of VH3810109 | 321.1 μg/mL |
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.
| Arm | Measure | Group | Value (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 ISRs | 0 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 ISRs | 0 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 ISRs | 7 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 ISRs | 5 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 ISRs | 2 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 ISRs | 14 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 ISRs | 0 Number of events |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of ISRs Events Overall and by Grade (Part 1 and 3) | Overall ISRs | 18 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 ISRs | 6 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 ISRs | 2 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 ISRs | 10 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 ISRs | 0 Number of events |
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.
| Arm | Measure | Group | Value (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 2 | 7 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 2 | 0 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 7 | 2 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 7 | 1 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 7 | 0 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 2 | 1 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 2 | 0 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 2 | 0 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 2 | 0 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 2 | 1 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 7 | 5 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 7 | 0 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 2 | 6 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 2 | 1 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 2 | 0 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 7 | 6 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 7 | 1 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 7 | 1 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 7 | 0 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 7 | 0 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 2 | 4 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 2 | 1 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 2 | 1 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 2 | 0 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 7 | 6 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 2 | 0 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 7 | 1 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 7 | 1 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 7 | 1 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 2 | 0 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 2 | 4 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 2 | 0 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 7 | 0 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 2 | 0 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 7 | 5 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 7 | 2 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 7 | 0 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 2 | 6 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 7 | 0 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 7 | 0 Participants |
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.
| Arm | Measure | Group | Value (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 2 | 2 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 2 | 0 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 2 | 0 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 2 | 0 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 7 | 3 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 7 | 0 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 2 | 6 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 7 | 5 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 7 | 0 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 7 | 0 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 7 | 0 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 2 | 2 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 7 | 0 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 7 | 5 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 2 | 0 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 2 | 6 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 2 | 0 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 2 | 0 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 7 | 3 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 7 | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Leukocyte esterase | 0 Participants |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Protein | 0 Participants |
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Glucose | 1 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Leukocyte esterase | 1 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Glucose | 0 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Protein | 1 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Leukocyte esterase | 1 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Glucose | 0 Participants |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline | Protein | 1 Participants |
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.
| Arm | Measure | Group | Value (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 2 | 1.44 Scores on a scale | Standard 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 7 | 1.44 Scores on a scale | Standard 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 7 | 1.50 Scores on a scale | Standard 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 2 | 1.44 Scores on a scale | Standard Deviation 0.496 |
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.
| Arm | Measure | Group | Value (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 1 | 3.63 Scores on a scale | Standard 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 2 | 3.63 Scores on a scale | Standard 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 7 | 3.63 Scores on a scale | Standard 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 1 | 2.75 Scores on a scale | Standard 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 2 | 0.63 Scores on a scale | Standard 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 7 | 0.38 Scores on a scale | Standard Deviation 0.744 |
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.
| Arm | Measure | Group | Value (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 1 | 0.50 Scores on a scale | Standard 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 2 | 0.88 Scores on a scale | Standard 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 7 | 0.50 Scores on a scale | Standard Deviation 1.414 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | The Overall Duration of ISRs, Expressed in Days | 2.9 Days | Standard Deviation 1.35 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | The Overall Duration of ISRs, Expressed in Days | 4.6 Days | Standard Deviation 6.29 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Time of Maximum Observed Concentration (Tmax) of VH3810109 | 4.503 Days |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Time of Maximum Observed Concentration (Tmax) of VH3810109 | 0.046 Days |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Time of Maximum Observed Concentration (Tmax) of VH3810109 | 2.882 Days |