Clinical trial for HIV Infections
Official title First Time in Human Study of Long Acting VH4524184 Formulations
ClinicalTrials.gov ID: NCT06310551
What this study is testing
What is Oral VH4524184?
Oral VH4524184 is an investigational medicine, taken by mouth, 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 study is looking for one or more doses of VH4524184 that are safe, well tolerated, and give the drug levels needed for a long‑acting HIV treatment.
- Who it's for
- Adults who are living with HIV‑1 infection.
- What's involved
- Participants will receive an injection of VH4524184 at different dose levels and will have blood tests and check‑ups to monitor safety and drug levels.
- 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
- Age -Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Type of Participant and Characteristics
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and...
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- Male or female
- Male Participants: No restrictions for male participants
You likely can't join if
- Medical Conditions
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of...
- Clinically significant abnormal blood pressure as determined by the investigator.
- 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.
See the full eligibility criteria
Who can join
- Age -Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Type of Participant and Characteristics
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- Male or female
- Male Participants: No restrictions for male participants
- A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.
- A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met. Informed Consent
- Capable of providing signed informed consent.
What rules you out
- Medical Conditions
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs
- Clinically significant abnormal blood pressure as determined by the investigator.
- 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.
- Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
- Underlying skin disease or disorder that would interfere with the administration of study product and/or assessment of injection site reactions.
- Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of /sensitivity to any of the study interventions including hyaluronidases.
- Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
- History of seizure.
- Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances, at the discretion of the investigator.
- Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.
- Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.
- Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and/or assessment of ISRs, if they occur.
- History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator.
- Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the...
- Receipt of any live vaccine(s) within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing. Prior/Concurrent Clinical Study Experience
- Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.
- Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of...
- Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.
- Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU...
- eGFR \ 1.1 x ULN.
- Hemoglobin \<12.5 g/dL for men and \<11 g/dL for women
- ALT or AST \> upper limit of normal (ULN).
- Total bilirubin \>1.5xULN.
- Any significant arrhythmia or ECG finding.
- Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.
- Presence of HBsAg and/or anti-HBc at Screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive pre-study drug/alcohol screen.
- Positive HIV antibody test. Other Exclusions
- Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females.
- Regular use of known drugs of abuse.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.
- Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.
- Fasting glucose \>125 mg/dL (6.95 mmol/L) or receiving treatment for elevated blood glucose.
- Triglycerides \>500 mg/dL (5.7 mmol/L) or receiving treatment for dyslipidemia.
The study team makes the final eligibility decision.
Where it is enrolling
- Lenexa, Kansas, United States
- Las Vegas, Nevada, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, 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, but 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?
This study is enrolling now at Lenexa, Kansas, United States; Las Vegas, Nevada, United States; Austin, Texas, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.