RECRUITING

A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV

Conditions

HIV Infections Human Immunodeficiency Virus (HIV)VH4527079 Monoclonal Antibody Safety Pharmacokinetics (PK)Healthy Adults Persons with HIV (PWH)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1, Open-Label, Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VH4527079, Administered Either Intravenously or Subcutaneously to Healthy Adults and Persons With HIV

Quick Facts

Study Start:2024-10-02

Study Completion:2027-02-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06652958

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 (ART) without history of virologic failure. HIV infection is documented by any licensed rapid HIV rest or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry. * 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. * Is not a Participant of childbearing potential (POCBP). OR * Is a POCBP and agrees to use a highly effective contraceptive method 3 weeks prior to the start of this study and during the study. * 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).	* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Weight \>115.0 kg. * Any medical condition that is not well controlled. * Positive HIV testing for participants enrolled in Arm A, Arm B Cohort 8, and Arm C. * Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study. * The participant has an underlying skin disease or disorder, piercing, or tattoos that would interfere with assessment of injection site reactions (ISRs). * History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy. * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. * Any condition which, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication. * Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease). * Known history of cirrhosis with or without viral hepatitis co-infection. * History of clinically relevant hepatitis within last 6 months. * For Cohort 9 (PWH in Arm B), untreated syphilis infection (i.e., positive syphilis testing at screening) without documentation of treatment. Participants who have successfully completed treatment at least 7 days previously are eligible if recruitment is open. Positive syphilis testing at screening for any other Cohort is exclusionary. * Lymphoma, leukemia, or any malignancy (except for breast cancer) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Participants who poses a significant suicidality risk. * Any pre-existing physical or mental condition which, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Any significant arrhythmia or ECG finding which, will interfere with the safety for the individual participant. * Exposure to an experimental drug, human blood product, anticoagulants, or experimental vaccine (which does not have emergency, conditional, or standard market authorization) within 30 days, or within 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention or plans to receive live vaccines during the study. * Any previous use of HIV Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) in Arm A (Cohorts 1 through 7) or Arm B (Cohort 8 only), or Arm C (Cohorts 10-14) either oral or parenteral, is exclusionary. * Any previous use of Neonatal Fc receptor blockers (e.g., efgartigimod alfa-fcab). * The participant has ever received an investigational HIV vaccine. * Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, HBV, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (Day 0). * Exposure to an experimental drug, human blood product, anticoagulants or vaccine (which does not have emergency, conditional, or standard market authorization) within 30 days, or within 5 half-lives of the test agents, or twice the duration of the biological effect of the test agents, whichever is longer, prior to the first dose of study treatment or plans to receive live vaccines during the study. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. * Exposure to more than 4 new chemical entities or vaccines within 12 months prior to the first dosing day. * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. * Participants who require concomitant medications known to be associated with a prolonged QTc. * Participants receiving any protocol-prohibited medication(s) and who are unwilling or unable to switch to an alternate medication.

Inclusion Criteria

Exclusion 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 (ART) without history of virologic failure. HIV infection is documented by any licensed rapid HIV rest or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry.
* 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.
* Is not a Participant of childbearing potential (POCBP). OR
* Is a POCBP and agrees to use a highly effective contraceptive method 3 weeks prior to the start of this study and during the study.
* 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).

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
* Weight \>115.0 kg.
* Any medical condition that is not well controlled.
* Positive HIV testing for participants enrolled in Arm A, Arm B Cohort 8, and Arm C.
* Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
* The participant has an underlying skin disease or disorder, piercing, or tattoos that would interfere with assessment of injection site reactions (ISRs).
* History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy.
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
* Any condition which, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
* Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease).
* Known history of cirrhosis with or without viral hepatitis co-infection.
* History of clinically relevant hepatitis within last 6 months.
* For Cohort 9 (PWH in Arm B), untreated syphilis infection (i.e., positive syphilis testing at screening) without documentation of treatment. Participants who have successfully completed treatment at least 7 days previously are eligible if recruitment is open. Positive syphilis testing at screening for any other Cohort is exclusionary.
* Lymphoma, leukemia, or any malignancy (except for breast cancer) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Participants who poses a significant suicidality risk.
* Any pre-existing physical or mental condition which, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
* Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
* Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Any significant arrhythmia or ECG finding which, will interfere with the safety for the individual participant.
* Exposure to an experimental drug, human blood product, anticoagulants, or experimental vaccine (which does not have emergency, conditional, or standard market authorization) within 30 days, or within 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention or plans to receive live vaccines during the study.
* Any previous use of HIV Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) in Arm A (Cohorts 1 through 7) or Arm B (Cohort 8 only), or Arm C (Cohorts 10-14) either oral or parenteral, is exclusionary.
* Any previous use of Neonatal Fc receptor blockers (e.g., efgartigimod alfa-fcab).
* The participant has ever received an investigational HIV vaccine.
* Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, HBV, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (Day 0).
* Exposure to an experimental drug, human blood product, anticoagulants or vaccine (which does not have emergency, conditional, or standard market authorization) within 30 days, or within 5 half-lives of the test agents, or twice the duration of the biological effect of the test agents, whichever is longer, prior to the first dose of study treatment or plans to receive live vaccines during the study.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
* Exposure to more than 4 new chemical entities or vaccines within 12 months prior to the first dosing day.
* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing.
* Participants who require concomitant medications known to be associated with a prolonged QTc.
* Participants receiving any protocol-prohibited medication(s) and who are unwilling or unable to switch to an alternate medication.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

GSK Investigational Site

Las Vegas, Nevada, 89113

United States

GSK Investigational Site

Austin, Texas, 78744

United States

Collaborators and Investigators

Sponsor: ViiV Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02

Study Completion Date2027-02-03

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2027-02-03

Terms related to this study

Keywords Provided by Researchers

Human Immunodeficiency Virus (HIV)
VH4527079
Monoclonal Antibody
Safety
Pharmacokinetics (PK)
Healthy Adults
Persons with HIV (PWH)

Additional Relevant MeSH Terms

HIV Infections