Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06724640 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV | PHASE1 | RECRUITING | 168 | — | — | Dec 16, 2024 | Aug 16, 2028 | Oct 29, 2025 | 2 | United States |
| NCT05393271 | First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants | PHASE1 | COMPLETED | 73 | — | — | Oct 3, 2022 | Apr 24, 2023 | Apr 1, 2025 | 2 | United States |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Number of participants who discontinued treatment due to AEs are presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. 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.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD=0.00 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 0.00.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis to determine AUC(0-inf). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Geometric Coefficient of Variation was expressed in percentages.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine AUC(0-t). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
| Arm | Type | Description |
|---|---|---|
| Single ascending dose (SAD) Group | EXPERIMENTAL | Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo. |
| Multiple ascending doses (MAD) Group | EXPERIMENTAL | Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo. |
| Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB) | PLACEBO_COMPARATOR | Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 25 mg PiB | PLACEBO_COMPARATOR | Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 125 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 200 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 625 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 1 (SAD): VH4011499 1875 mg PiB | EXPERIMENTAL | Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28. |
| Part 2 Multiple Ascending Dose (MAD): Placebo PiB | PLACEBO_COMPARATOR | Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 200 mg PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42. |
| Part 2 (MAD): VH4011499 400 mg PiB | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42. |
| Part 3 (Single dose): VH4011499 200 mg tablet | EXPERIMENTAL | Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28. |
| Name | Type | Description |
|---|---|---|
| VH4011499 low dose Injection | DRUG | VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly. |
| VH4011499 high dose Injection | DRUG | VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly. |
| Placebo | DRUG | Placebo Injection will be administered either subcutaneously or intramuscularly. |
| VH4011499 | DRUG | VH4011499 will be administered. |
| Midazolam | DRUG | Midazolam will be administered |
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy. * Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not plann...