VH4367310 in healthy adults: testing single increasing doses for safety and how it behaves in the body
Official title: A Phase 1 Double-blind (Sponsor-unblinded), Placebo-controlled, Randomized, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VH4367310 Administered to Healthy Adult Participants
Run by ViiV Healthcare · NCT07818915 · Data updated 2026-11-12
This study tests a single rising dose of VH4367310, a cabotegravir prodrug, to see how it behaves in the body and how safe and tolerable it is in healthy adults aged 18 to 55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | ViiV Healthcare Industry-sponsored |
| Locations | 2 sites (Glendale, California and 1 other locations) |
| Status | Recruiting |
| Started | September 15, 2026 |
| Main results expected | December 26, 2028 |
| Study ends | December 26, 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07818915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 who meet weight and BMI criteria and agree to contraception/childbearing requirements as applicable.
✕Probably not a fit
Individuals with significant health conditions or those not meeting the eligibility criteria may not experience any direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human study assesses pharmacokinetics, safety, and tolerability of intramuscular VH4367310 given as a single increasing dose in healthy adults. Participants are 18 to 55 years old and must be generally healthy, with specific weight and BMI requirements. The study compares VH4367310 to placebo in a controlled setting across two sites in the United States. Outcomes focus on how the drug is absorbed, distributed, metabolized, and eliminated, along with any adverse effects observed. The trial is sponsored by ViiV Healthcare and conducted at GSK investigational sites in Glendale, CA and Baltimore, MD.
Why it matters
Potential benefit: If successful, the study could provide early information on dosing and safety for VH4367310 as a potential future HIV treatment option.
How similar studies have gone: Prior similar pharmacokinetic and safety assessments of cabotegravir prodrugs have informed development, but VH4367310 here is being tested in a new context as a single-dose intramuscular formulation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 dose of study intervention. Participants assigned female at birth are eligible to participate if they are a participant of non-childbearing potential (PONCBP). * Capable of giving written informed consent. Exclusion Criteria: * Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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. * 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 of injection site reactions. * 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. Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
Where it's running
-
GSK Investigational Site
Glendale, California, United States Recruiting -
GSK Investigational Site
Baltimore, Maryland, United States Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.