NCT06724640 · ViiV Healthcare
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
What this study is about
The purpose of this study is to investigate safety, how the drug moves through the body and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered injected under the skin (SC) and intramuscularly (IM) in participants without HIV.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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 criteria
- 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.
Where
- Las Vegas, Nevada
- Austin, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations