Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A, Cohort 1 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion. |
|
| Arm A, Cohort 2 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion. |
|
| Arm A, Cohort 3 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion. |
|
| Arm A, Cohort 4 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion. |
|
| Arm A, Cohort 5 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion. |
|
| Arm A, Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4527079 | Biological | VH4527079 solution for injection or infusion will be administered either by SC injection or IV infusion respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) of Grade 2 and above 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 AEs 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 24 follow-up period |
| Area under the plasma-concentration time curve from time zero to infinity (AUC 0-inf) of VH4527079 | From Day 1 Up to Week 24 follow-up period | |
| Area under the plasma-concentration time curve from time zero to the last quantifiable concentration (AUC 0-tlast) of VH4527079 | From Day 1 Up to Week 24 follow-up period | |
| Area under the plasma-concentration time curve from defined interval between doses (AUCtau) of VH4527079 | From Day 1 Up to Week 24 follow-up period | |
| Maximum observed plasma concentration (Cmax) of VH4527079 | From Day 1 Up to Week 24 follow-up period | |
| Time to maximum observed plasma concentration (Tmax) of VH4527079 | From Day 1 Up to Week 24 follow-up period | |
| Apparent terminal half-life (t1/2) of VH4527079 | From Day 1 Up to Week 24 follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of VH4527079 after a single dose administered via SC route relative to IV administration | From Day 1 Up to Week 24 follow-up period | |
| AUC0-tlast of VH4527079 after a single dose administered via SC route relative to IV administration | From Day 1 Up to Week 24 follow-up period |
Not provided
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 based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study).
Body weight more than or equal to (>=)50.0 kg for men and >=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m^2.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not pregnant or breastfeeding and, at least, one of the following conditions apply:
Capable of giving signed informed consent.
Willing to have samples stored for future research for participants in Arm B; Cohort 8 (Healthy Volunteers) and Cohort 9 (PWH in Arm B).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Las Vegas | Nevada | 89113 | United States | ||
| GSK Investigational Site |
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.
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion. |
|
| Arm A, Cohort 7 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection. |
|
| Arm B, Cohort 8 | Experimental | Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
|
| Arm B, Cohort 9 | Experimental | Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
|
| Cmax of VH4527079 after a single dose administered via SC route relative to IV administration | From Day 1 Up to Week 24 follow-up period |
| Post-baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin & Fasting lipid panel (milligrams per deciliter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for chemistry panels: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter) | Chemistry panels included Aspartate aminotransferase (AST)/ Serum glutamic-oxalo-acetic transaminase (SGOT), Alanine aminotransferase (ALT)/ Serum glutamic-pyruvic transaminase (SGPT), Alkaline phosphatase (ALP) and Creatinine phosphokinase (CPK) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for chemistry panels: Total Protein (Grams per deciliter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Platelet count (cells per microliter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Red Blood Cell (RBC) Count (million cells per microliter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Hemoglobin (Hgb) (grams per deciliter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Mean Corpuscular Volume (MCV) (Femtoliters) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Mean Corpuscular Hemoglobin (MCH) (Picograms) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for coagulation panels: Prothrombin time (PT) and Partial Thromboplastin Time (PTT) (Seconds) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Post-baseline values for coagulation panels: International normalized ratio (INR) (Ratio) | From Day 1 (pre-Dose 1) Up to Week 24 follow-up period |
| Change from baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin and Fasting lipid panel (milligrams per deciliter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for chemistry panels: AST/ SGOT, ALT/ SGPT, ALP and CPK (International Units per liter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for chemistry panels: Total Protein (Grams per deciliter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: Platelet count (cells per microliter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: RBC Count (million cells per microliter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: Hgb (grams per deciliter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: MCV (Femtoliters) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: MCH (Picograms) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for coagulation panels: PT and PTT (Seconds) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Change from baseline values for coagulation panels: INR (Ratio) | From Day 1 (pre-Dose 1) up to Week 24 follow-up period |
| Number of participants with maximum post-baseline QT interval corrected (QTc) values compared to baseline by category | QTc values will be categorized as no change= number of participants with QTc values less than or equal to (<=)450 milliseconds (msec), any increase= number of participants with QTc values more than (>)450 - 480 msec, number of participants with QTc values >480 -500 msec, and number of participants with QTc values >500 msec | Up to Week 24 follow-up period |
| Number of participants with maximum post-baseline increases in QTc values compared to baseline by category | Post-baseline increase in QTc values will be categorized by number of participants with QTc value increase of <=30 msec, number of participants with QTc value increase of 31 - 60 msec, and number of participants with QTc value increase of >60 msec | Up to Week 24 follow-up period |
| Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic and systolic blood pressure | Number of participants with post-baseline changes will be categorized as change to low, change to within range or no change, and change to high | Up to Week 24 follow-up period |
| Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for pulse rate | Number of participants with post-baseline changes will be categorized as change to low, change to within range or no change, and change to high | Up to Week 24 follow-up period |
| Number of participants with any AEs and AEs by 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 AEs 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 24 follow-up period |
| Number of participants who discontinue treatment due to AEs | Up to Week 24 follow-up period |
| Austin |
| Texas |
| 78744 |
| United States |
| 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 |