HIV Infections study: VH4367310
Official title A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07818915
What this study is testing
What is VH4367310?
This is an investigational injectable medicine being studied for HIV infections. It is designed to release cabotegravir, a drug that helps stop HIV from making copies of itself.
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
- This study is testing whether the new drug VH4367310 works safely in the body. It looks at how the drug moves through the body and how well it is tolerated.
- Who it's for
- You may be able to join if you are a healthy adult between 18 and 55 years old.
- What's involved
- You will receive a single shot of the drug in your muscle. The team will check how the drug behaves in your body and watch for any side effects.
- Time commitment
- The study lasts a few weeks, with a few visits to give the shot and check your health.
- Phase 1: an early, usually small safety study
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 greater than or equal to (\>=) 18 years and less than or equal to (\<=) 55 years of age, at the time of signing the informed...
- Participants who are overtly healthy as determined by medical evaluation.
- Body weight \>=40 kg and BMI within the range \>=18 to \<=32 kg/m\^2.
- Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during...
- Capable of giving written informed consent.
You likely can't join if
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders...
- 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...
- Unstable liver disease or known hepatic or biliary abnormalities.
- History of clinically relevant hepatitis within last 6 months.
- History of cirrhosis with or without viral hepatitis co-infection.
- Participants determined by the investigator to have a high risk of seizures.
See the full eligibility criteria
- Participant must be greater than or equal to (\>=) 18 years and less than or equal to (\<=) 55 years of age, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation.
- Body weight \>=40 kg and BMI within the range \>=18 to \<=32 kg/m\^2.
- Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during the study intervention period and for at least 90 days after the last...
- Capable of giving written informed consent.
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, 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.
- Unstable liver disease or known hepatic or biliary abnormalities.
- History of clinically relevant hepatitis within last 6 months.
- History of cirrhosis with or without viral hepatitis co-infection.
- Participants determined by the investigator to have a high risk of seizures.
- Participant who poses a significant suicidality risk.
- Current or anticipated need for chronic anti-coagulation therapy.
- Hereditary coagulation or platelet disorders.
- Any acute laboratory abnormality at screening that would preclude participation or exclusionary laboratory value.
- Abnormal blood pressure.
- ALT \>1.5x upper limit of normal (ULN). Total bilirubin \>1.5x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5x ULN as long as direct bilirubin is \<=1.5x ULN.
- Hemoglobin \<12.5 g/dL for men and \<11 g/dL for women.
- Creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2).
- Presence of HbsAg and/or HbcAb 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 HIV antibody/antigen test (HIV-1 ± HIV-2).
- Current enrolment or past participation in another investigational study in which an experimental drug or experimental vaccine was administered.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Past participation in another investigational clinical study in which long-acting CAB was administered or any CAB use for pre-exposure prophylaxis (PrEP).
- History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or another allergy.
- Participant has an implant/enhancement (including fillers); or tattoo or other dermatological condition overlying the area for IM or SC injection or any other area which may significantly interfere with interpretation...
- History of or ongoing high-risk behaviors that may put the participant at increased risk for HIV.
- 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.
- Positive pre-study drug/alcohol screen.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, California, United States
- Baltimore, Maryland, 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 Glendale, California, United States; Baltimore, Maryland, 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.