HIV Infections
Conditions
Keywords
HIV-1, VH4004280, VH4011499, Treatment Naïve, Phase 2a, Monotherapy
Brief summary
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
Interventions
DRUGVH4004280
VH4004280 was administered as tablets orally at Day 1.
DRUGVH4011499
VH4011499 was administered as tablets orally at Day 1 and Day 6.
DRUGVH4004280 Matching Placebo
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
DRUGVH4011499 Matching Placebo
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
DRUGAntiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who are overtly healthy (other than HIV-1 infection). * Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL). * Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter (mL). * Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary. * Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m\^2). * Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control. * Participants capable of giving signed informed consent. * Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period.
Exclusion criteria
* Women who are breastfeeding or plan to become pregnant or breast feed during the study. * Participants with acute HIV infection. * Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease. * Untreated syphilis infection. * Ongoing malignancy other than certain localised malignancies. * Treatment with immunomodulating agents or any agent with known anti-HIV activity. * Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition. * Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication. * Participants having exclusionary electrocardiogram (ECG) findings. * Participants who have been exposed to any prohibited medication or vaccine. * Participant positive for hepatitis B or hepatitis C. * Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality). * Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | From Baseline (Day 1) and up to Day 11 | Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL). |
| Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | From Baseline (Day 1) and up to Day 11 | Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monotherapy: Number of Participants With AEs by Severity | From Baseline (Day 1) and up to Day 11 | Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death. |
| Follow-up: Number of Participants With AEs by Severity | From Day 11 and up to Day 39 | Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death. |
| Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation | From Baseline (Day 1) and up to Day 11 | 'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention. |
| Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39 | Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000. |
| Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39 | Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000. |
| Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39 | Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. |
| Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39 | Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. |
| Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | From Baseline (Day 1) and up to Day 39 | Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. |
| Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | From Baseline (Day 1) and up to Day 39 | Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. |
| Monotherapy: Number of Participants With Any Adverse Events (AEs) | From Baseline (Day 1) and up to Day 11 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention. |
| Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | From Baseline (Day 1) and up to Day 39 | Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. |
| Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax) | After dose administration at Day 1 | Cmax is defined as the maximum concentration of the drug in plasma. |
| Monotherapy, VH4011499: Cmax | After dose administration at Day 1 and Day 6 | Cmax is defined as the maximum concentration of the drug in plasma. |
| Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax) | After dose administration at Day 1 | Tmax is a measure of the time required to reach the maximum concentration of the drug. |
| Monotherapy, VH4011499: Tmax | After dose administration at Day 1 and Day 6 | Tmax is a measure of the time required to reach the maximum concentration of the drug. |
| Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11) | At Day 11 | C11 is defined as the concentration of the drug in plasma at Day 11. |
| Monotherapy, VH4011499: C11 | At Day 11 | C11 is defined as the concentration of the drug in plasma at Day 11. |
| Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | At Baseline (Day 1) and Day 11 | Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. |
| Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | At Baseline (Day 1) and Day 11 | Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. |
| Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | From Baseline (Day 1) and up to Day 39 | Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. |
| Follow-up: Number of Participants With Any AEs | From Day 11 and up to Day 39 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention. |
Countries
Argentina, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
All participants that were enrolled started the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1a: VH4004280 Dose Level 1 Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39. | 6 |
| Part 1a: VH4004280 Dose Level 2 Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 6 |
| Part 2a: VH4004280 Pre-specified Dose Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 6 |
| Matching Placebo for VH4004280 Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 3 |
| Part 1b: VH4011499 Dose Level 1 Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39. | 7 |
| Part 1b: VH4011499 Dose Level 2 Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 6 |
| Part 2b: VH4011499 Pre-specified Dose Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 7 |
| Matching Placebo for VH4011499 Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39. | 3 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Follow-Up (Day 11-Day 39) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1a: VH4004280 Dose Level 1 | Part 1a: VH4004280 Dose Level 2 | Part 2a: VH4004280 Pre-specified Dose | Matching Placebo for VH4004280 | Part 1b: VH4011499 Dose Level 1 | Part 1b: VH4011499 Dose Level 2 | Part 2b: VH4011499 Pre-specified Dose | Matching Placebo for VH4011499 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.3 YEARS STANDARD_DEVIATION 12.82 | 42.8 YEARS STANDARD_DEVIATION 10.3 | 31.5 YEARS STANDARD_DEVIATION 9.75 | 28.7 YEARS STANDARD_DEVIATION 9.29 | 31.6 YEARS STANDARD_DEVIATION 9.29 | 49.3 YEARS STANDARD_DEVIATION 7.45 | 28.6 YEARS STANDARD_DEVIATION 9.93 | 26 YEARS STANDARD_DEVIATION 2.65 | 34.8 YEARS STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 7 Participants | 3 Participants | 3 Participants | 2 Participants | 31 Participants |
| Sex/Gender, Customized Female | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 7 Participants |
| Sex/Gender, Customized Male | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 7 Participants | 3 Participants | 6 Participants | 3 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 7 | 0 / 6 | 0 / 7 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 7 | 0 / 6 | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 3 / 6 | 2 / 6 | 2 / 6 | 2 / 3 | 2 / 7 | 4 / 6 | 2 / 7 | 1 / 3 | 1 / 6 | 3 / 6 | 4 / 6 | 1 / 3 | 3 / 7 | 3 / 6 | 5 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 7 | 0 / 6 | 0 / 7 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 7 | 0 / 6 | 0 / 7 | 0 / 3 |
Outcome results
Primary
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
Time frame: From Baseline (Day 1) and up to Day 11
Population: Analysis was performed on Full Analysis Set (FAS) population, which included all randomized participants who received at least one full dose of study treatment. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Baseline (Day 1) | 5.004 log10 c/mL | Standard Deviation 0.4592 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Maximum change compared to Baseline (Day 1) | -1.056 log10 c/mL | Standard Deviation 0.4567 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Maximum change compared to Baseline (Day 1) | -1.391 log10 c/mL | Standard Deviation 0.6986 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Baseline (Day 1) | 4.923 log10 c/mL | Standard Deviation 0.5428 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Baseline (Day 1) | 4.866 log10 c/mL | Standard Deviation 0.7696 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Maximum change compared to Baseline (Day 1) | -1.983 log10 c/mL | Standard Deviation 0.2171 |
| Matching Placebo for VH4004280 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Baseline (Day 1) | 4.636 log10 c/mL | Standard Deviation 0.6641 |
| Matching Placebo for VH4004280 | Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 | Maximum change compared to Baseline (Day 1) | -0.070 log10 c/mL | Standard Deviation 0.0574 |
Primary
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: From Baseline (Day 1) and up to Day 11
Population: Analysis was performed on FAS population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Baseline (Day 1) | 5.001 log10 c/mL | Standard Deviation 0.7304 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Maximum change compared to Baseline (Day 1) | -1.834 log10 c/mL | Standard Deviation 0.5141 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Maximum change compared to Baseline (Day 1) | -1.797 log10 c/mL | Standard Deviation 0.4544 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Baseline (Day 1) | 4.339 log10 c/mL | Standard Deviation 0.6185 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Baseline (Day 1) | 4.960 log10 c/mL | Standard Deviation 0.7288 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Maximum change compared to Baseline (Day 1) | -2.165 log10 c/mL | Standard Deviation 0.431 |
| Matching Placebo for VH4004280 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Baseline (Day 1) | 4.714 log10 c/mL | Standard Deviation 0.7736 |
| Matching Placebo for VH4004280 | Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 | Maximum change compared to Baseline (Day 1) | -0.176 log10 c/mL | Standard Deviation 0.1969 |
Secondary
Follow-up: Number of Participants With AEs by Severity
Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Time frame: From Day 11 and up to Day 39
Population: Analysis was performed on Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 1 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 3 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 2 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 2 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 2 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 3 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With AEs by Severity | Grade 1 | 0 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With AEs by Severity | Grade 2 | 0 Participants |
Secondary
Follow-up: Number of Participants With Any AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Time frame: From Day 11 and up to Day 39
Population: Analysis was performed on Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Follow-up: Number of Participants With Any AEs | 1 Participants |
| Part 1a: VH4004280 Dose Level 2 | Follow-up: Number of Participants With Any AEs | 3 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Follow-up: Number of Participants With Any AEs | 4 Participants |
| Matching Placebo for VH4004280 | Follow-up: Number of Participants With Any AEs | 1 Participants |
| Part 1b: VH4011499 Dose Level 1 | Follow-up: Number of Participants With Any AEs | 3 Participants |
| Part 1b: VH4011499 Dose Level 2 | Follow-up: Number of Participants With Any AEs | 3 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Follow-up: Number of Participants With Any AEs | 5 Participants |
| Matching Placebo for VH4011499 | Follow-up: Number of Participants With Any AEs | 0 Participants |
Secondary
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1) | 31.3 International units per liter (IU/L) | Standard Deviation 13.59 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 18 | -0.5 International units per liter (IU/L) | Standard Deviation 3.33 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 39 | 0.6 International units per liter (IU/L) | Standard Deviation 4.16 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 32 | -9.2 International units per liter (IU/L) | Standard Deviation 11.97 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 25 | 1.0 International units per liter (IU/L) | Standard Deviation 11.17 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 11 | -5.0 International units per liter (IU/L) | Standard Deviation 2.94 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 11 | -6.3 International units per liter (IU/L) | Standard Deviation 6.34 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 39 | -9.8 International units per liter (IU/L) | Standard Deviation 11.12 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1) | 26.0 International units per liter (IU/L) | Standard Deviation 4.94 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 9 | -6.0 International units per liter (IU/L) | Standard Deviation 13.69 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 25 | -4.7 International units per liter (IU/L) | Standard Deviation 9.35 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day 1) | 79.2 International units per liter (IU/L) | Standard Deviation 14.4 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 11 | -8.8 International units per liter (IU/L) | Standard Deviation 15.78 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 6 | -7.8 International units per liter (IU/L) | Standard Deviation 9.33 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 9 | -5.0 International units per liter (IU/L) | Standard Deviation 6 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 2 | -1.3 International units per liter (IU/L) | Standard Deviation 7.87 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 2 | -3.5 International units per liter (IU/L) | Standard Deviation 3.62 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 39 | -6.6 International units per liter (IU/L) | Standard Deviation 5.5 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 32 | 3.2 International units per liter (IU/L) | Standard Deviation 21.1 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 4 | 0.6 International units per liter (IU/L) | Standard Deviation 5.41 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 18 | -6.2 International units per liter (IU/L) | Standard Deviation 14.16 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 2 | -2.8 International units per liter (IU/L) | Standard Deviation 3.25 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 7 | -4.8 International units per liter (IU/L) | Standard Deviation 4.54 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 6 | 1.5 International units per liter (IU/L) | Standard Deviation 6.75 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 4 | -3.6 International units per liter (IU/L) | Standard Deviation 3.21 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 32 | -5.0 International units per liter (IU/L) | Standard Deviation 6.81 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 4 | -3.8 International units per liter (IU/L) | Standard Deviation 4.09 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 7 | -0.2 International units per liter (IU/L) | Standard Deviation 6.24 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 18 | -4.7 International units per liter (IU/L) | Standard Deviation 6.44 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 7 | -6.7 International units per liter (IU/L) | Standard Deviation 9.77 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 6 | -4.8 International units per liter (IU/L) | Standard Deviation 4.36 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 9 | -0.2 International units per liter (IU/L) | Standard Deviation 2.95 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 25 | -6.8 International units per liter (IU/L) | Standard Deviation 15.48 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 9 | -4.3 International units per liter (IU/L) | Standard Deviation 6.09 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 4 | -0.8 International units per liter (IU/L) | Standard Deviation 0.75 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 11 | -4.8 International units per liter (IU/L) | Standard Deviation 6.05 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 2 | -1.8 International units per liter (IU/L) | Standard Deviation 3.25 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 18 | -7.0 International units per liter (IU/L) | Standard Deviation 5.4 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 25 | -0.3 International units per liter (IU/L) | Standard Deviation 3.56 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 2 | -0.8 International units per liter (IU/L) | Standard Deviation 2.71 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 25 | -5.0 International units per liter (IU/L) | Standard Deviation 4.69 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 32 | -2.7 International units per liter (IU/L) | Standard Deviation 10.84 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1) | 21.5 International units per liter (IU/L) | Standard Deviation 4.23 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 39 | -5.5 International units per liter (IU/L) | Standard Deviation 7.82 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 9 | -0.7 International units per liter (IU/L) | Standard Deviation 9.63 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1) | 21.7 International units per liter (IU/L) | Standard Deviation 7.17 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 11 | -2.0 International units per liter (IU/L) | Standard Deviation 6.26 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 18 | 0.0 International units per liter (IU/L) | Standard Deviation 6.51 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 18 | -0.2 International units per liter (IU/L) | Standard Deviation 4.45 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 25 | -0.5 International units per liter (IU/L) | Standard Deviation 2.17 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 4 | -2.3 International units per liter (IU/L) | Standard Deviation 2.8 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 11 | -2.0 International units per liter (IU/L) | Standard Deviation 4.6 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 32 | -0.3 International units per liter (IU/L) | Standard Deviation 4.23 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 39 | 0.5 International units per liter (IU/L) | Standard Deviation 3.39 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 39 | -0.3 International units per liter (IU/L) | Standard Deviation 3.5 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 32 | -1.3 International units per liter (IU/L) | Standard Deviation 3.08 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 9 | -1.5 International units per liter (IU/L) | Standard Deviation 4.72 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day 1) | 74.3 International units per liter (IU/L) | Standard Deviation 15.74 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 2 | -2.7 International units per liter (IU/L) | Standard Deviation 10.03 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 6 | -1.3 International units per liter (IU/L) | Standard Deviation 1.51 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 7 | -2.2 International units per liter (IU/L) | Standard Deviation 2.23 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 4 | -5.0 International units per liter (IU/L) | Standard Deviation 5.9 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 6 | -4.5 International units per liter (IU/L) | Standard Deviation 6.35 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 6 | -2.0 International units per liter (IU/L) | Standard Deviation 1.26 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 7 | -6.2 International units per liter (IU/L) | Standard Deviation 2.71 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 7 | -2.0 International units per liter (IU/L) | Standard Deviation 3.03 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 32 | -3.8 International units per liter (IU/L) | Standard Deviation 8.47 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1) | 33.2 International units per liter (IU/L) | Standard Deviation 13.23 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 2 | -0.2 International units per liter (IU/L) | Standard Deviation 3.56 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 4 | 0.2 International units per liter (IU/L) | Standard Deviation 6.1 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 6 | 2.2 International units per liter (IU/L) | Standard Deviation 8.13 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 7 | 0.2 International units per liter (IU/L) | Standard Deviation 7.39 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 9 | 1.5 International units per liter (IU/L) | Standard Deviation 12.1 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 11 | -0.2 International units per liter (IU/L) | Standard Deviation 11.99 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 18 | 8.3 International units per liter (IU/L) | Standard Deviation 27.46 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 25 | 1.7 International units per liter (IU/L) | Standard Deviation 14.54 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 32 | 0.3 International units per liter (IU/L) | Standard Deviation 12.32 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 39 | -4.0 International units per liter (IU/L) | Standard Deviation 8.72 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day 1) | 71.7 International units per liter (IU/L) | Standard Deviation 19.39 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 2 | -1.0 International units per liter (IU/L) | Standard Deviation 3.16 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 4 | -2.6 International units per liter (IU/L) | Standard Deviation 2.51 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 6 | 0.7 International units per liter (IU/L) | Standard Deviation 5.35 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 7 | -2.0 International units per liter (IU/L) | Standard Deviation 4.52 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 9 | -3.5 International units per liter (IU/L) | Standard Deviation 5.82 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 11 | -5.8 International units per liter (IU/L) | Standard Deviation 8.28 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 18 | -2.7 International units per liter (IU/L) | Standard Deviation 8.5 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 25 | -1.3 International units per liter (IU/L) | Standard Deviation 8.71 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 39 | -2.2 International units per liter (IU/L) | Standard Deviation 4.15 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1) | 27.2 International units per liter (IU/L) | Standard Deviation 3.49 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 2 | -0.2 International units per liter (IU/L) | Standard Deviation 4.09 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 4 | 0.8 International units per liter (IU/L) | Standard Deviation 3.96 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 6 | 0.7 International units per liter (IU/L) | Standard Deviation 5.54 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 7 | -1.2 International units per liter (IU/L) | Standard Deviation 4.88 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 9 | 2.5 International units per liter (IU/L) | Standard Deviation 8.53 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 11 | 7.0 International units per liter (IU/L) | Standard Deviation 22.52 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 18 | 4.2 International units per liter (IU/L) | Standard Deviation 16.46 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 25 | 1.5 International units per liter (IU/L) | Standard Deviation 7.4 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 32 | 0.7 International units per liter (IU/L) | Standard Deviation 4.72 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 39 | -2.4 International units per liter (IU/L) | Standard Deviation 3.13 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 4 | -1.0 International units per liter (IU/L) | Standard Deviation 5.29 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 7 | -6.0 International units per liter (IU/L) | Standard Deviation 4.36 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 6 | -2.3 International units per liter (IU/L) | Standard Deviation 1.15 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 6 | -13.7 International units per liter (IU/L) | Standard Deviation 27.14 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 6 | -8.3 International units per liter (IU/L) | Standard Deviation 11.06 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 4 | -1.0 International units per liter (IU/L) | Standard Deviation 3.61 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 2 | -3.0 International units per liter (IU/L) | Standard Deviation 3 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 4 | 4.7 International units per liter (IU/L) | Standard Deviation 9.29 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 7 | -9.0 International units per liter (IU/L) | Standard Deviation 9.85 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Baseline (Day 1) | 64.3 International units per liter (IU/L) | Standard Deviation 16.8 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 39 | -33.0 International units per liter (IU/L) | Standard Deviation 54.62 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 39 | -10.3 International units per liter (IU/L) | Standard Deviation 13.65 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 9 | -9.3 International units per liter (IU/L) | Standard Deviation 10.69 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 32 | -33.0 International units per liter (IU/L) | Standard Deviation 56.4 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 25 | -27.7 International units per liter (IU/L) | Standard Deviation 44.5 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 32 | -9.0 International units per liter (IU/L) | Standard Deviation 14.8 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 11 | -6.7 International units per liter (IU/L) | Standard Deviation 5.03 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 18 | -15.7 International units per liter (IU/L) | Standard Deviation 31.18 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 11 | -16.7 International units per liter (IU/L) | Standard Deviation 29.74 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 2 | 15.0 International units per liter (IU/L) | Standard Deviation 29.46 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 18 | -1.0 International units per liter (IU/L) | Standard Deviation 3.61 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 9 | -20.7 International units per liter (IU/L) | Standard Deviation 35.81 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 39 | 0.3 International units per liter (IU/L) | Standard Deviation 3.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 32 | -5.3 International units per liter (IU/L) | Standard Deviation 5.77 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Day 7 | -19.3 International units per liter (IU/L) | Standard Deviation 32.62 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Baseline (Day 1) | 29.7 International units per liter (IU/L) | Standard Deviation 11.72 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 25 | -5.0 International units per liter (IU/L) | Standard Deviation 4.36 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 18 | -4.3 International units per liter (IU/L) | Standard Deviation 4.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT, Baseline (Day 1) | 52.7 International units per liter (IU/L) | Standard Deviation 55.82 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 2 | 11.0 International units per liter (IU/L) | Standard Deviation 26 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 11 | -6.3 International units per liter (IU/L) | Standard Deviation 4.93 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP, Day 9 | -6.3 International units per liter (IU/L) | Standard Deviation 6.66 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST, Day 25 | -11.3 International units per liter (IU/L) | Standard Deviation 11.93 |
Secondary
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.410 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | 1.154 Micromole per liter (µmol/L) | Standard Deviation 1.5758 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | 0.923 Micromole per liter (µmol/L) | Standard Deviation 1.3712 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 0.770 Micromole per liter (µmol/L) | Standard Deviation 2.1596 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | 0.684 Micromole per liter (µmol/L) | Standard Deviation 2.6513 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | 0.547 Micromole per liter (µmol/L) | Standard Deviation 1.0073 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | 0.570 Micromole per liter (µmol/L) | Standard Deviation 1.1731 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 6.641 Micromole per liter (µmol/L) | Standard Deviation 1.5157 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | -0.171 Micromole per liter (µmol/L) | Standard Deviation 3.5771 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | -0.143 Micromole per liter (µmol/L) | Standard Deviation 1.7719 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 1.539 Micromole per liter (µmol/L) | Standard Deviation 1.4307 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 1.060 Micromole per liter (µmol/L) | Standard Deviation 2.523 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 8.408 Micromole per liter (µmol/L) | Standard Deviation 5.5383 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | -0.513 Micromole per liter (µmol/L) | Standard Deviation 2.9697 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | -2.081 Micromole per liter (µmol/L) | Standard Deviation 3.5614 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | 0.485 Micromole per liter (µmol/L) | Standard Deviation 3.6055 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 0.941 Micromole per liter (µmol/L) | Standard Deviation 3.3295 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 0.656 Micromole per liter (µmol/L) | Standard Deviation 4.2584 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | 1.539 Micromole per liter (µmol/L) | Standard Deviation 1.867 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | 0.399 Micromole per liter (µmol/L) | Standard Deviation 2.4005 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | 0.513 Micromole per liter (µmol/L) | Standard Deviation 3.0049 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | -0.542 Micromole per liter (µmol/L) | Standard Deviation 2.5557 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | -1.197 Micromole per liter (µmol/L) | Standard Deviation 3.291 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.410 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | 0.002 Micromole per liter (µmol/L) | Standard Deviation 0.0041 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | 0.030 Micromole per liter (µmol/L) | Standard Deviation 0.0739 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 0.059 Micromole per liter (µmol/L) | Standard Deviation 0.1437 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | 0.002 Micromole per liter (µmol/L) | Standard Deviation 0.0041 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.174 Micromole per liter (µmol/L) | Standard Deviation 0.4221 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.030 Micromole per liter (µmol/L) | Standard Deviation 0.0739 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | 1.984 Micromole per liter (µmol/L) | Standard Deviation 3.1078 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 0.599 Micromole per liter (µmol/L) | Standard Deviation 2.4774 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | 0.030 Micromole per liter (µmol/L) | Standard Deviation 0.0739 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 6.926 Micromole per liter (µmol/L) | Standard Deviation 4.63 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | -1.340 Micromole per liter (µmol/L) | Standard Deviation 3.2199 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 1.055 Micromole per liter (µmol/L) | Standard Deviation 1.7752 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | -2.195 Micromole per liter (µmol/L) | Standard Deviation 3.5417 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | 0.239 Micromole per liter (µmol/L) | Standard Deviation 4.4814 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | -1.881 Micromole per liter (µmol/L) | Standard Deviation 3.4709 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.410 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | 0.085 Micromole per liter (µmol/L) | Standard Deviation 1.2649 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | 2.366 Micromole per liter (µmol/L) | Standard Deviation 5.2755 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | -0.513 Micromole per liter (µmol/L) | Standard Deviation 3.2332 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | 0.002 Micromole per liter (µmol/L) | Standard Deviation 0.0041 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | 0.456 Micromole per liter (µmol/L) | Standard Deviation 2.8682 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.410 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 1.767 Micromole per liter (µmol/L) | Standard Deviation 3.2189 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 6.783 Micromole per liter (µmol/L) | Standard Deviation 1.237 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | 2.565 Micromole per liter (µmol/L) | Standard Deviation 2.846 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | -1.767 Micromole per liter (µmol/L) | Standard Deviation 1.5516 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | 1.995 Micromole per liter (µmol/L) | Standard Deviation 3.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | -0.342 Micromole per liter (µmol/L) | Standard Deviation 1.8016 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | -0.741 Micromole per liter (µmol/L) | Standard Deviation 2.2771 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | -0.171 Micromole per liter (µmol/L) | Standard Deviation 2.736 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 1.026 Micromole per liter (µmol/L) | Standard Deviation 3.6194 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | 0.000 Micromole per liter (µmol/L) | Standard Deviation 0 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 0.969 Micromole per liter (µmol/L) | Standard Deviation 3.7672 |
Secondary
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Time frame: From Baseline (Day 1) and up to Day 39
Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 1 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 1 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 1 Participants |
Secondary
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Time frame: From Baseline (Day 1) and up to Day 39
Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 1 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
Secondary
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Baseline (Day 1) | 14.9 IU/L | Standard Deviation 4.41 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 18 | -0.1 IU/L | Standard Deviation 6.01 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 39 | -2.4 IU/L | Standard Deviation 13.72 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 32 | 4.0 IU/L | Standard Deviation 13.62 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 25 | 2.4 IU/L | Standard Deviation 7.59 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 11 | 2.9 IU/L | Standard Deviation 13.32 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 11 | -1.6 IU/L | Standard Deviation 3.74 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 39 | 0.0 IU/L | Standard Deviation 7.84 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Baseline (Day 1) | 18.6 IU/L | Standard Deviation 3.87 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 9 | -0.3 IU/L | Standard Deviation 1.98 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 25 | 1.6 IU/L | Standard Deviation 5.86 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Baseline (Day 1) | 81.1 IU/L | Standard Deviation 14.55 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 11 | 0.0 IU/L | Standard Deviation 3.32 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 6 | -0.1 IU/L | Standard Deviation 1.57 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 9 | 0.0 IU/L | Standard Deviation 3 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 2 | 1.0 IU/L | Standard Deviation 5.6 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 2 | -0.7 IU/L | Standard Deviation 2.43 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 39 | 0.0 IU/L | Standard Deviation 5.43 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 32 | 0.3 IU/L | Standard Deviation 9.05 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 4 | 2.7 IU/L | Standard Deviation 6.97 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 18 | 0.3 IU/L | Standard Deviation 5.19 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 2 | 1.7 IU/L | Standard Deviation 1.25 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 7 | -1.7 IU/L | Standard Deviation 4.07 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 6 | -1.4 IU/L | Standard Deviation 7.44 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 4 | 1.1 IU/L | Standard Deviation 4.45 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 32 | 2.8 IU/L | Standard Deviation 9.97 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 4 | 2.4 IU/L | Standard Deviation 1.72 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 7 | 3.9 IU/L | Standard Deviation 5.7 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 18 | -1.3 IU/L | Standard Deviation 5.82 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 7 | 0.1 IU/L | Standard Deviation 2.54 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 6 | -0.9 IU/L | Standard Deviation 4.02 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 9 | 0.0 IU/L | Standard Deviation 9.8 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 25 | 2.0 IU/L | Standard Deviation 9.02 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 9 | -1.5 IU/L | Standard Deviation 1.76 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 4 | -2.7 IU/L | Standard Deviation 3.27 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 11 | -1.3 IU/L | Standard Deviation 3.2 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 2 | -1.2 IU/L | Standard Deviation 1.83 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 18 | -3.2 IU/L | Standard Deviation 3.92 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 25 | -0.5 IU/L | Standard Deviation 4.32 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 2 | -2.3 IU/L | Standard Deviation 2.8 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 25 | -5.0 IU/L | Standard Deviation 5.76 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 32 | -4.5 IU/L | Standard Deviation 3.45 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Baseline (Day 1) | 24.0 IU/L | Standard Deviation 8.07 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 39 | -2.2 IU/L | Standard Deviation 8.04 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 9 | -0.2 IU/L | Standard Deviation 4.07 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Baseline (Day 1) | 19.5 IU/L | Standard Deviation 9.03 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 11 | -1.2 IU/L | Standard Deviation 3.76 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 18 | -3.2 IU/L | Standard Deviation 5.31 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 18 | -1.3 IU/L | Standard Deviation 4.46 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 25 | 0.0 IU/L | Standard Deviation 5.66 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 4 | -1.0 IU/L | Standard Deviation 3.85 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 11 | -2.2 IU/L | Standard Deviation 4.79 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 32 | -2.7 IU/L | Standard Deviation 3.88 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 39 | 1.3 IU/L | Standard Deviation 2.58 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 39 | 0.8 IU/L | Standard Deviation 4.49 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 32 | -1.4 IU/L | Standard Deviation 3.13 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 9 | -2.7 IU/L | Standard Deviation 4.41 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Baseline (Day 1) | 68.2 IU/L | Standard Deviation 18.9 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 2 | -1.2 IU/L | Standard Deviation 2.48 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 6 | -1.2 IU/L | Standard Deviation 3.76 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 7 | -3.5 IU/L | Standard Deviation 5.75 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 4 | -2.5 IU/L | Standard Deviation 3.33 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 6 | -3.7 IU/L | Standard Deviation 5.75 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 6 | -1.5 IU/L | Standard Deviation 5.68 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 7 | -4.5 IU/L | Standard Deviation 3.39 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 7 | -1.5 IU/L | Standard Deviation 4.76 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 32 | -3.7 IU/L | Standard Deviation 9.81 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Baseline (Day 1) | 31.7 IU/L | Standard Deviation 22.6 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 2 | -1.6 IU/L | Standard Deviation 3.78 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 4 | -3.6 IU/L | Standard Deviation 13.2 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 6 | -5.1 IU/L | Standard Deviation 14.58 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 7 | -7.3 IU/L | Standard Deviation 14.91 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 9 | -8.0 IU/L | Standard Deviation 16.42 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 11 | -7.3 IU/L | Standard Deviation 11.71 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 18 | -4.0 IU/L | Standard Deviation 17.91 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 25 | -7.4 IU/L | Standard Deviation 17.52 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 32 | -10.3 IU/L | Standard Deviation 16.63 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 39 | -3.6 IU/L | Standard Deviation 15.87 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Baseline (Day 1) | 78.9 IU/L | Standard Deviation 20.69 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 2 | 0.6 IU/L | Standard Deviation 6.48 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 4 | -4.9 IU/L | Standard Deviation 13.38 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 6 | -3.6 IU/L | Standard Deviation 4.69 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 7 | -0.4 IU/L | Standard Deviation 8.66 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 9 | -1.4 IU/L | Standard Deviation 9.76 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 11 | -1.6 IU/L | Standard Deviation 7.96 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 18 | -2.9 IU/L | Standard Deviation 6.49 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 25 | -6.4 IU/L | Standard Deviation 10.97 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 39 | -1.7 IU/L | Standard Deviation 14.69 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Baseline (Day 1) | 24.7 IU/L | Standard Deviation 7.2 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 2 | -2.0 IU/L | Standard Deviation 1.29 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 4 | 1.7 IU/L | Standard Deviation 7.5 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 6 | -2.4 IU/L | Standard Deviation 3.55 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 7 | -3.7 IU/L | Standard Deviation 5.12 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 9 | -4.3 IU/L | Standard Deviation 5.02 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 11 | -2.1 IU/L | Standard Deviation 3.29 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 18 | 2.4 IU/L | Standard Deviation 9.55 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 25 | -2.6 IU/L | Standard Deviation 4.86 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 32 | -2.9 IU/L | Standard Deviation 6.69 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 39 | 1.7 IU/L | Standard Deviation 10.64 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 4 | -2.3 IU/L | Standard Deviation 0.58 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 7 | 4.0 IU/L | Standard Deviation 8.72 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 6 | 6.3 IU/L | Standard Deviation 8.33 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 6 | 0.7 IU/L | Standard Deviation 1.15 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 6 | -1.7 IU/L | Standard Deviation 3.21 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 4 | -0.7 IU/L | Standard Deviation 7.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 2 | -0.3 IU/L | Standard Deviation 1.53 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 4 | -1.0 IU/L | Standard Deviation 1 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 7 | -5.7 IU/L | Standard Deviation 2.31 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Baseline (Day 1) | 89.3 IU/L | Standard Deviation 16.5 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 39 | 28.0 IU/L | Standard Deviation 28.28 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 39 | 23.0 IU/L | Standard Deviation 5.66 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 9 | -5.0 IU/L | Standard Deviation 6.24 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 32 | 3.0 IU/L | Standard Deviation 4.36 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 25 | 0.7 IU/L | Standard Deviation 0.58 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 32 | -2.3 IU/L | Standard Deviation 4.93 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 11 | -4.7 IU/L | Standard Deviation 7.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 18 | 1.7 IU/L | Standard Deviation 2.52 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 11 | 0.0 IU/L | Standard Deviation 3.61 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 2 | 0.7 IU/L | Standard Deviation 0.58 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 18 | -0.3 IU/L | Standard Deviation 5.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 9 | -0.3 IU/L | Standard Deviation 2.08 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 39 | 1.0 IU/L | Standard Deviation 11.31 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 32 | -2.3 IU/L | Standard Deviation 8.02 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Day 7 | -0.7 IU/L | Standard Deviation 1.57 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Baseline (Day 1) | 27.7 IU/L | Standard Deviation 5.51 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 25 | -1.7 IU/L | Standard Deviation 17.21 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 18 | 2.3 IU/L | Standard Deviation 9.71 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Baseline (Day 1) | 18.3 IU/L | Standard Deviation 2.08 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 2 | -2.3 IU/L | Standard Deviation 3.21 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 11 | 10.3 IU/L | Standard Deviation 14.47 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Day 9 | -0.7 IU/L | Standard Deviation 8.08 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Day 25 | -3.7 IU/L | Standard Deviation 0.58 |
Secondary
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | -0.075 µmol/L | Standard Deviation 0.1977 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.485 µmol/L | Standard Deviation 0.1977 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | 1.050 µmol/L | Standard Deviation 2.0766 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | -0.075 µmol/L | Standard Deviation 0.1977 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | 0.239 µmol/L | Standard Deviation 1.3927 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 0.599 µmol/L | Standard Deviation 2.9175 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | -0.366 µmol/L | Standard Deviation 2.7081 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | 0.122 µmol/L | Standard Deviation 2.3975 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | 0.366 µmol/L | Standard Deviation 3.9024 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | -0.057 µmol/L | Standard Deviation 0.2395 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | -0.073 µmol/L | Standard Deviation 0.1983 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 5.643 µmol/L | Standard Deviation 2.4898 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | -0.171 µmol/L | Standard Deviation 2.4741 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | -0.928 µmol/L | Standard Deviation 0.9095 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | -0.075 µmol/L | Standard Deviation 0.1977 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | -0.049 µmol/L | Standard Deviation 0.2197 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 0.366 µmol/L | Standard Deviation 3.4476 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | -0.087 µmol/L | Standard Deviation 0.2135 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | -0.073 µmol/L | Standard Deviation 0.1939 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | -0.057 µmol/L | Standard Deviation 0.1396 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | -0.440 µmol/L | Standard Deviation 2.3774 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.027 µmol/L | Standard Deviation 0.1571 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | 0.002 µmol/L | Standard Deviation 0.0041 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 7.524 µmol/L | Standard Deviation 2.6579 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | 0.114 µmol/L | Standard Deviation 0.9951 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | -0.656 µmol/L | Standard Deviation 0.9937 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | -1.967 µmol/L | Standard Deviation 2.6286 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | -0.200 µmol/L | Standard Deviation 2.7111 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | -0.228 µmol/L | Standard Deviation 1.4004 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | -0.884 µmol/L | Standard Deviation 1.3439 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | -0.057 µmol/L | Standard Deviation 1.7989 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | 0.798 µmol/L | Standard Deviation 3.2258 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 0.513 µmol/L | Standard Deviation 3.3017 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | -0.599 µmol/L | Standard Deviation 1.7861 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.410 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.000 µmol/L | Standard Deviation 0 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | 0.030 µmol/L | Standard Deviation 0.0739 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.230 µmol/L | Standard Deviation 0.5626 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | 0.000 µmol/L | Standard Deviation 0 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | 1.808 µmol/L | Standard Deviation 2.3463 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | 0.367 µmol/L | Standard Deviation 1.4081 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 4.544 µmol/L | Standard Deviation 1.7576 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | 0.586 µmol/L | Standard Deviation 1.7739 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 1.099 µmol/L | Standard Deviation 1.4804 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | 1.295 µmol/L | Standard Deviation 2.1332 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | 0.611 µmol/L | Standard Deviation 1.6008 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 1.075 µmol/L | Standard Deviation 2.2398 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.705 µmol/L | Standard Deviation 0.7794 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | 0.709 µmol/L | Standard Deviation 2.3036 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | 0.440 µmol/L | Standard Deviation 1.437 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | 0.489 µmol/L | Standard Deviation 2.263 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | -0.295 µmol/L | Standard Deviation 0.7794 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 39 | -0.855 µmol/L | Standard Deviation 0.2418 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Baseline (Day 1) | 3.527 µmol/L | Standard Deviation 0.2032 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 25 | -0.114 µmol/L | Standard Deviation 0.1975 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 2 | -0.117 µmol/L | Standard Deviation 0.2032 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 7 | -1.995 µmol/L | Standard Deviation 3.6569 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Baseline (Day 1) | 7.011 µmol/L | Standard Deviation 2.2361 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 4 | -0.114 µmol/L | Standard Deviation 0.1975 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 6 | -0.117 µmol/L | Standard Deviation 0.2032 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 6 | -2.109 µmol/L | Standard Deviation 3.6529 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 7 | 1.140 µmol/L | Standard Deviation 2.2862 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 4 | -0.570 µmol/L | Standard Deviation 1.5516 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 9 | -0.057 µmol/L | Standard Deviation 0.0987 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 32 | 0.114 µmol/L | Standard Deviation 0.1975 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 11 | -0.117 µmol/L | Standard Deviation 0.2032 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 2 | -0.855 µmol/L | Standard Deviation 0.6165 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 18 | 1.083 µmol/L | Standard Deviation 3.4427 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 18 | 0.057 µmol/L | Standard Deviation 0.0987 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 25 | -1.026 µmol/L | Standard Deviation 3.0059 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 11 | -2.964 µmol/L | Standard Deviation 1.237 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 32 | 0.627 µmol/L | Standard Deviation 4.9452 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Day 39 | -0.171 µmol/L | Standard Deviation 0.2418 |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Day 9 | 0.912 µmol/L | Standard Deviation 3.5924 |
Secondary
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Time frame: From Baseline (Day 1) and up to Day 39
Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 1 | 1 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALP, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | ALT, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST | AST, Increase to Grade 1 | 1 Participants |
Secondary
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Time frame: From Baseline (Day 1) and up to Day 39
Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 2 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Total Bilirubin, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 1 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 4 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 3 | 1 Participants |
| Matching Placebo for VH4004280 | Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin | Direct Bilirubin, Increase to Grade 2 | 0 Participants |
Secondary
Monotherapy: Number of Participants With AEs by Severity
Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Time frame: From Baseline (Day 1) and up to Day 11
Population: Analysis was performed on Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 3 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 2 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 1 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 3 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 2 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs by Severity | Grade 5 | 0 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs by Severity | Grade 4 | 0 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs by Severity | Grade 1 | 1 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs by Severity | Grade 3 | 0 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs by Severity | Grade 2 | 0 Participants |
Secondary
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.
Time frame: From Baseline (Day 1) and up to Day 11
Population: Analysis was performed on Safety Population, which included all participants that received at least one study intervention. Discontinuation of treatment was not possible for participants that received VH4004280 or matching placebo for VH4004280, since these participants received only one dose intervention at Day 1 (all planned interventions as per protocol schedule).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation | 0 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation | 0 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation | 0 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation | 0 Participants |
Secondary
Monotherapy: Number of Participants With Any Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Time frame: From Baseline (Day 1) and up to Day 11
Population: Analysis was performed on Safety Population, which included all randomized participants who received at least 1 dose of study treatment and had safety data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 3 Participants |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 2 Participants |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 2 Participants |
| Matching Placebo for VH4004280 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 2 Participants |
| Part 1b: VH4011499 Dose Level 1 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 2 Participants |
| Part 1b: VH4011499 Dose Level 2 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 4 Participants |
| Part 2b: VH4011499 Pre-specified Dose | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 2 Participants |
| Matching Placebo for VH4011499 | Monotherapy: Number of Participants With Any Adverse Events (AEs) | 1 Participants |
Secondary
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Time frame: At Baseline (Day 1) and Day 11
Population: Analysis was performed on FAS population. Only participants that received VH4004280 intervention and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 5.004 log10 c/mL | Standard Deviation 0.4592 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -0.941 log10 c/mL | Standard Deviation 0.6608 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 4.923 log10 c/mL | Standard Deviation 0.5428 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -1.322 log10 c/mL | Standard Deviation 0.7727 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 4.866 log10 c/mL | Standard Deviation 0.7696 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -1.939 log10 c/mL | Standard Deviation 0.1124 |
Secondary
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
Cmax is defined as the maximum concentration of the drug in plasma.
Time frame: After dose administration at Day 1
Population: Analysis was performed on Pharmacokinetic (PK) population, which included all participants in the Safety analysis population who had at least 1 non-missing PK assessment. Data was reported according to the actual study treatment. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax) | 131.57 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 77.68 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax) | 364.70 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 85.21 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax) | 473.00 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 54.23 |
Secondary
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
C11 is defined as the concentration of the drug in plasma at Day 11.
Time frame: At Day 11
Population: Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11) | 18.07 ng/mL | Geometric Coefficient of Variation 132.07 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11) | 48.53 ng/mL | Geometric Coefficient of Variation 130.33 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11) | 50.42 ng/mL | Geometric Coefficient of Variation 41.52 |
Secondary
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Time frame: After dose administration at Day 1
Population: Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax) | 7.95 Hour (h) |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax) | 9.00 Hour (h) |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax) | 8.04 Hour (h) |
Secondary
Monotherapy, VH4011499: C11
C11 is defined as the concentration of the drug in plasma at Day 11.
Time frame: At Day 11
Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoint were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: C11 | 11.16 ng/mL | Geometric Coefficient of Variation 50.02 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: C11 | 10.56 ng/mL | Geometric Coefficient of Variation 36.61 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: C11 | 27.04 ng/mL | Geometric Coefficient of Variation 50.68 |
Secondary
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Time frame: At Baseline (Day 1) and Day 11
Population: Analysis was performed on FAS population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 5.001 log10 c/mL | Standard Deviation 0.7304 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -1.801 log10 c/mL | Standard Deviation 0.5165 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 4.339 log10 c/mL | Standard Deviation 0.6185 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -1.750 log10 c/mL | Standard Deviation 0.4962 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Baseline (Day 1) | 4.960 log10 c/mL | Standard Deviation 0.7288 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline | Day 11 | -2.165 log10 c/mL | Standard Deviation 0.431 |
Secondary
Monotherapy, VH4011499: Cmax
Cmax is defined as the maximum concentration of the drug in plasma.
Time frame: After dose administration at Day 1 and Day 6
Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Cmax | Day 1 | 27.63 ng/mL | Geometric Coefficient of Variation 94.53 |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Cmax | Day 6 | 35.30 ng/mL | Geometric Coefficient of Variation 81.31 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Cmax | Day 1 | 31.88 ng/mL | Geometric Coefficient of Variation 26.58 |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Cmax | Day 6 | 32.31 ng/mL | Geometric Coefficient of Variation 25.97 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Cmax | Day 1 | 133.59 ng/mL | Geometric Coefficient of Variation 42.34 |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Cmax | Day 6 | 141.18 ng/mL | Geometric Coefficient of Variation 47.79 |
Secondary
Monotherapy, VH4011499: Tmax
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Time frame: After dose administration at Day 1 and Day 6
Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Tmax | Day 1 | 9.95 h |
| Part 1a: VH4004280 Dose Level 1 | Monotherapy, VH4011499: Tmax | Day 6 | 10.00 h |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Tmax | Day 1 | 9.88 h |
| Part 1a: VH4004280 Dose Level 2 | Monotherapy, VH4011499: Tmax | Day 6 | 10.04 h |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Tmax | Day 1 | 8.00 h |
| Part 2a: VH4004280 Pre-specified Dose | Monotherapy, VH4011499: Tmax | Day 6 | 11.52 h |