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The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4011499 low dose Injection | Drug | VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale | 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. | Up to Week 78 |
| Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group | Up to Week 78 | |
| Area under the plasma concentration vs time curve (AUC0-tau) for MAD group | Up to Week 78 | |
| Maximum observed plasma concentration (Cmax) of VH4011499 | Up to Week 78 | |
| Time to maximum observed plasma concentration (tmax) of VH4011499 | Up to Week 78 | |
| Apparent terminal half-life (t1/2) of VH4011499 | Up to Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group | At Day 4, Day 10, Week 4, Week 24 and Week 48 | |
| Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for MAD group |
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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 planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies:
Capable of giving signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Las Vegas | Nevada | 89113 | United States |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| 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. |
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| At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 |
| Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for SAD group | At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1) |
| Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for MAD group | At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1) |
| Number of participants with maximum toxicity grade change from baseline in liver chemistry parameters: total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) | Baseline (Prior to Day 1) and Up to Week 78 |
| Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for SAD group | At Day 4, Day 10, Week 4, Week 24 and Week 48 |
| Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for MAD group | At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 |
| Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for SAD group | At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1) |
| Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for MAD group | At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 compared to Baseline (Prior to Day 1) |
| Number of participants with Grade 1 AEs (including ISR AEs) as per severity using the DAIDS grading scale | 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. | Week 78 post dose (Week 82 for MAD Group) |
| Duration of ISR (Days) AEs by grade using the DAIDS grading scale | Week 78 post dose (Week 82 for MAD Group) |
| GSK Investigational Site | Recruiting | Austin | Texas | 78744 | United States |
|
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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