The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy.
Is a Participant of Nonchildbearing potential (PONCBP)
Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric 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.
Abnormal blood pressure.
Lymphoma, leukemia, 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.
Breast cancer within the past 10 years.
Sequential
VH4011499 low dose Injection
DrugVH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
VH4011499 high dose Injection
DrugVH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
Placebo
DrugPlacebo Injection will be administered either subcutaneously or intramuscularly.
Number of participants with adverse events (AEs), including Injection Site Reaction (ISR) AEs, as per severity of Grade 2-5 using the DAIDS grading scale
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. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group
Area under the plasma concentration vs time curve (AUC0-tau) for MAD group
Maximum observed plasma concentration (Cmax) of VH4011499
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for MAD group
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for SAD group
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for MAD group
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