RECRUITING

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

Conditions

HIV Infections Human Immunodeficiency Virus (HIV)VH4011499 Safety Tolerability Pharmacokinetics Healthy participants Long-Acting Injection Single ascending dose Multiple ascending dose

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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

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.

Official Title

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV

Quick Facts

Study Start:2024-12-16

Study Completion:2028-08-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06724640

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. * 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: * Is a Participant of Nonchildbearing potential (PONCBP) * Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy. * Capable of giving signed informed consent.	* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders 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. * Abnormal blood pressure. * Lymphoma, leukemia, or any malignancy 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. * Breast cancer within the past 10 years. * Current or chronic history of liver disease, or known hepatic or biliary abnormalities. * History of clinically relevant hepatitis within last 6 months. * Patients with chronic hepatitis B infection. * History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation. * The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites. * Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded. * History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition. * Any preexisting 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. * Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing * Exposure to more than 4 new investigational products within 12 months prior to the first dosing day. * Current enrollment or recent past participation in another investigational study. * Positive HIV antibody/antigen test. * ALT more than or equal to (\>=)1.5x upper limit of normal (ULN), Total bilirubin \>=1.5x ULN (isolated total bilirubin more than (\>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (\<)60 millilitre per minute (mL/min)/1.73 square meter (m\^2). * Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec. * Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (\>3 seconds). * The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.

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.
* 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:
* Is a Participant of Nonchildbearing potential (PONCBP)
* Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.
* Capable of giving signed informed consent.

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders 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.
* Abnormal blood pressure.
* Lymphoma, leukemia, or any malignancy 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.
* Breast cancer within the past 10 years.
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
* History of clinically relevant hepatitis within last 6 months.
* Patients with chronic hepatitis B infection.
* History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
* The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
* Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded.
* History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition.
* Any preexisting 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.
* Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing
* Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
* Current enrollment or recent past participation in another investigational study.
* Positive HIV antibody/antigen test.
* ALT more than or equal to (\>=)1.5x upper limit of normal (ULN), Total bilirubin \>=1.5x ULN (isolated total bilirubin more than (\>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (\<)60 millilitre per minute (mL/min)/1.73 square meter (m\^2).
* Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec.
* Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (\>3 seconds).
* The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.

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 Date2024-12-16

Study Completion Date2028-08-16

Study Record Updates

Study Start Date2024-12-16

Study Completion Date2028-08-16

Terms related to this study

Keywords Provided by Researchers

Human Immunodeficiency Virus (HIV)
VH4011499
Safety
Tolerability
Pharmacokinetics
Healthy participants
Long-Acting Injection
Single ascending dose
Multiple ascending dose

Additional Relevant MeSH Terms

HIV Infections