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.
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/m².
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).
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.
Sequential
VH4367310
DrugVH4367310 will be administered intramuscularly.
Placebo
DrugPlacebo will be administered intramuscularly.
Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB
Maximum observed plasma concentration (Cmax) of VH4367310 and CAB
Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB
Number of participants with drug-related adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Number of participants with changes in ECG parameters over time
Number of participants with changes in laboratory parameters over time
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
