A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV

Korábbi kezelés

• Previous exposure to the parent molecule VH4524184.
• Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.
• Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention.
• Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.

Más betegség

• 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.
• Positive HIV antibody/antigen test.
• History of clinically relevant hepatitis within the last 6 months.
• Positive hepatitis B or hepatitis C test.
• Clinically significant cardiovascular disease..
• Resting heart rate (HR) <50 or >100 beats per minute (bpm) when vital signs are measured at Screening or Check-in.
  • The criteria presented above represent a subset of the key exclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol.

Laborértékek

• Any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 milliseconds (msec) and >480 msec (bundle branch block).

Egyéb

• Current enrolment or participation in another clinical study.
• Blood pressure (BP) >140/90 (systolic BP/diastolic BP [SBP/DBP]).

• 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/m\^2 (inclusive).
• Participants of any sex (male or female) are eligible. A female participant (female sex assigned at birth) is eligible to participate if they are a person of non-childbearing potential (PONCBP).
• Capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • The criteria presented above represent a subset of the key inclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol.