The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.
Participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF).
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
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/m² (inclusive).
History or presence of, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, 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.
History of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates study participation.
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.
Any preexisting physical or mental condition which, in the opinion of the investigator or the medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
Parallel
VH5356136 Formulation 1
DrugParticipants will receive VH5356136 Formulation 1 on Day 1.
VH5356136 Formulation 2
DrugParticipants will receive VH5356136 Formulation 2 on Day 1.
Placebo for VH5356136 Formulation 1
DrugParticipants will receive placebo for VH5356136 Formulation 1 on Day 1.
Placebo for VH5356136 Formulation 2
DrugParticipants will receive placebo for VH5356136 Formulation 2 on Day 1.
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. A drug-related AE is an AE that, in the opinion of the investigator, is related to one of the study interventions.
Number of participants with Grade 2 to Grade 5 AEs
The grading of AEs is performed based on the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale, here Grade 2 = moderate, Grade 3=severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.
Area under the concentration time curve from zero (pre-dose) to the last quantifiable concentration (post dose) (AUC[0-tlast]) for VH5356136
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
The laboratory abnormalities are assessed using the DAIDS grading scale, where Grade 3 = severe and Grade 4 = potentially life-threatening.
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