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The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280 | Experimental | VH4004280 injections are administered subcutaneously (SC), SC+ rHuPH20, or intramuscularly (IM). |
|
| Part 1: Participants Receiving Placebo | Placebo Comparator | Placebo injection is administered. |
|
| Part 2 SAD: Participants Receiving VH4011499 | Experimental | VH4011499 injections are administered SC, SC+ rHuPH20, or IM. |
|
| Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499 | Experimental | VH4011499 injections are administered IM. |
|
| Part 2: Participants Receiving Placebo | Placebo Comparator | Placebo injection is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4004280 | Drug | VH4004280 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SAD: Number of Participants with Adverse Events (AEs) as per Severity | 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 Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity. | Up to Week 52 |
| MAD: Number of Participants with Adverse Events (AEs) as per Severity | 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 Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity. | Up to Week 56 |
| SAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L]) | Up to Week 52 | |
| MAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L]) | Up to Week 56 | |
| SAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Las Vegas | Nevada | 89113 | United States | ||
| GSK Investigational Site |
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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| Placebo | Drug | Placebo will be administered. |
|
| VH4011499 | Drug | VH4011499 will be administered. |
|
| Baseline (Prior to Day 1) and up to Week 52 |
| MAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L) | Baseline (Prior to Day 1) and up to Week 56 |
| SAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) | Up to Week 52 |
| MAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) | Up to Week 56 |
| SAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter) | Up to Week 52 |
| MAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter) | Up to Week 56 |
| SAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter) | Baseline (Prior to Day 1) and up to Week 52 |
| MAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter) | Baseline (Prior to Day 1) and up to Week 56 |
| SAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale | DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity. | Up to Week 52 |
| MAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale | DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity. | Up to Week 56 |
| SAD: Duration of ISR (Days) AE | Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent. | Up to Week 52 |
| MAD: Duration of ISR (Days) AE | Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent. | Up to Week 56 |
| Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4004280 | Up to Week 52 |
| Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4011499 | Up to Week 56 |
| Maximum Observed Plasma Concentration (Cmax) of VH4004280 | Up to Week 52 |
| Maximum Observed Plasma Concentration (Cmax) of VH4011499 | Up to Week 56 |
| Time of Maximum Observed Plasma Concentration (tmax) of VH4004280 | Up to Week 52 |
| Time of Maximum Observed Plasma Concentration (tmax) of VH4011499 | Up to Week 56 |
| Apparent Terminal Half-life (t1/2) of VH4004280 | Up to Week 52 |
| Apparent Terminal Half-life (t1/2) of VH4011499 | Up to Week 56 |
| 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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