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A Study of VH4011499 in Adults Without HIV

This study is looking into VH4011499, a new injectable medication, to see how safe it is, how well people tolerate it, and how it moves through the body. Researchers are comparing different doses of VH4011499 (low and high) to a placebo (an inactive substance) in adults who do not have HIV. The medication will be given as an injection under the skin or into a muscle. The main goals are to track any side effects, especially at the injection site, and to understand how much of the medication is in the body over time. You may be able to join if you are a healthy adult between 18 and 55 years old. The study aims to enroll 168 participants.

Study design
This is an interventional study comparing different doses of VH4011499 to a placebo. It plans to enroll 168 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and medication levels for up to 78 weeks.

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NCT06724640

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
ViiV Healthcare
~168 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:VH4011499 low dose InjectionVH4011499 high dose InjectionPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale
Measured over Up to Week 78
+5 more outcomes measured

Conditions

HIV Infections

Explore related trials

HIV Infection

Where it's being run

2 sites across 2 states
Nevada1
Texas1

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scaleUp to Week 78

    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 and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, 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.

  • Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD groupUp to Week 78
  • Area under the plasma concentration vs time curve (AUC0-tau) for MAD groupUp to Week 78
  • Maximum observed plasma concentration (Cmax) of VH4011499Up to Week 78
  • Time to maximum observed plasma concentration (tmax) of VH4011499Up to Week 78
  • Apparent terminal half-life (t1/2) of VH4011499Up to Week 78