A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

ViiV Healthcare

Status and phase: Enrolling; Phase 1

Conditions: HIV Infections

Treatments: Drug: Placebo; Drug: VH4011499 high dose Injection; Drug: VH4011499 low dose Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06724640

218547

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

• Participants who are overtly healthy.

• Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies:

  • 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.

• Capable of giving signed informed consent.

Exclusion criteria

• 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.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
• History of clinically relevant hepatitis within last 6 months.
• Patients with chronic hepatitis B infection.
• History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
• The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
• Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded.
• History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition.
• Any preexisting physical or mental condition which 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.
• Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing
• Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
• Current enrollment or recent past participation in another investigational study.
• Positive HIV antibody/antigen test.
• ALT more than or equal to (>=)1.5x upper limit of normal (ULN), Total bilirubin >=1.5x ULN (isolated total bilirubin more than (>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (<)60 millilitre per minute (mL/min)/1.73 square meter (m^2).
• Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse.
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec.
• Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (>3 seconds).
• The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Single ascending dose (SAD) Group

Experimental group

Description:

Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo.

Treatment:

Drug: VH4011499 low dose Injection

Drug: VH4011499 high dose Injection

Drug: Placebo

Multiple ascending doses (MAD) Group

Experimental group

Description:

Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo.

Treatment:

Drug: VH4011499 low dose Injection

Drug: VH4011499 high dose Injection

Drug: Placebo