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Compares treatment options for HIV Infections
Official title A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
ClinicalTrials.gov ID: NCT06724640
What this study is testing
What is VH4011499 low dose Injection?
VH4011499 low dose Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Las Vegas, Nevada, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Vegas, Nevada, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.