ACTIVE_NOT_RECRUITING

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults

Conditions

HIV Infections Healthy participants Human Immunodeficiency Virus (HIV-1)VH4004280 VH4011499 Long-Acting Injection Single 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 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.

Official Title

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults

Quick Facts

Study Start:2023-08-24

Study Completion:2026-06-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06012136

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
* Participants who are overtly healthy. * Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1. * Male or female participants of non-childbearing potential. * 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 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 capsid inhibitor intramuscular (gluteus medius) administration. * History of or on-going high-risk behaviours that may put the participant at increased risk for HIV. * Past or intended use of over-the-counter or prescription medication including herbal medications. * Current enrollment or recent past participation in another investigational study. * Exposure to more than 4 investigational products within 12 months prior to dosing. * Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin \>1.5xULN), and/or estimated creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2). * History of or current infection with hepatitis B or hepatitis C. * Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission. * Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse. * Positive HIV antibody/antigen test. * Abnormal electrocardiogram (ECG) parameters. * 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 (gluteal) which may interfere with interpretation of injection site reactions or administration of study product.

Inclusion Criteria

Exclusion Criteria

* Participants who are overtly healthy.
* Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
* Male or female participants of non-childbearing potential.
* 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 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 capsid inhibitor intramuscular (gluteus medius) administration.
* History of or on-going high-risk behaviours that may put the participant at increased risk for HIV.
* Past or intended use of over-the-counter or prescription medication including herbal medications.
* Current enrollment or recent past participation in another investigational study.
* Exposure to more than 4 investigational products within 12 months prior to dosing.
* Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin \>1.5xULN), and/or estimated creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2).
* History of or current infection with hepatitis B or hepatitis C.
* Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission.
* Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.
* Positive HIV antibody/antigen test.
* Abnormal electrocardiogram (ECG) parameters.
* 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 (gluteal) which may interfere with interpretation of injection site reactions or administration of study product.

Contacts and Locations

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 Date2023-08-24

Study Completion Date2026-06-09

Study Record Updates

Study Start Date2023-08-24

Study Completion Date2026-06-09

Terms related to this study

Keywords Provided by Researchers

Healthy participants
Human Immunodeficiency Virus (HIV-1)
VH4004280
VH4011499
Long-Acting Injection
Single ascending dose

Additional Relevant MeSH Terms

HIV Infections