A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants

Korábbi kezelés

• Current or anticipated need for chronic anti-coagulation therapy.
• 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.
• 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.
• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
• 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.

Más betegség

• 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.
• Positive HIV antibody/antigen test (HIV-1 ± HIV-2).
• 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.

Laborértékek

• Hereditary coagulation or platelet disorders.
• Any acute laboratory abnormality at screening that would preclude participation or exclusionary laboratory value.
• 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).

Egyéb

• Participant who poses a significant suicidality risk.
• Abnormal blood pressure.
• Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
• Past participation in another investigational clinical study in which long-acting CAB was administered or any CAB use for pre-exposure prophylaxis (PrEP).

• 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.