A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
RecruitingPhase 1Healthy volunteers welcome
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
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility 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.
About the study
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
What is being tested
- VH4367310 (drug)
- Placebo (drug)
Sponsor: ViiV Healthcare · Participants: 112 · Started: Sep 15, 2026
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT07818915
Locations in the U.S.
| California | GSK Investigational Site, Glendale |
| Maryland | GSK Investigational Site, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.