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New treatment option 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, given as a pill 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 purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
- 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. 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 negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. Weight
- Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all...
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
- 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 negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. Weight
- Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range...
- Male or female
- Male Participants: No restrictions for male participants
- Participants of female sex assigned at birth:
- 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; constituting a risk when taking the study drug, interfering with...
- 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. This includes participants in HIV discordant relationships, or men who...
- 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) or vaccines against SARS-CoV-2 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 \>1.5x 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. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 mL) of...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lenexa, Kansas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Lenexa, Kansas, United States; San Antonio, Texas, United States; Salt Lake City, Utah, 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.