Recruiting
Phase 1

VH4011499

Sponsor:

ViiV Healthcare

Code:

NCT06724640

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

VH4011499 low dose Injection

VH4011499 high dose Injection

Placebo

Study Details

Brief summary:

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.

Conditions

HIV Infections

Study ID

NCT06724640

Start date

Dec 16, 2024

Status verified date

Oct, 2025

Completion date

Aug 16, 2028

Anticipated

Primary completion date

Aug 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single ascending dose (SAD) Group

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

experimental: Multiple ascending doses (MAD) Group

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

Interventions

VH4011499 low dose Injection

VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.

VH4011499 high dose Injection

VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.

Placebo

Placebo Injection will be administered either subcutaneously or intramuscularly.

Primary outcome measure

  • 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 [ Time Frame: Up to Week 78 ]
  • Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group [ Time Frame: Up to Week 78 ]
  • Area under the plasma concentration vs time curve (AUC0-tau) for MAD group [ Time Frame: Up to Week 78 ]
  • Maximum observed plasma concentration (Cmax) of VH4011499 [ Time Frame: Up to Week 78 ]
  • Time to maximum observed plasma concentration (tmax) of VH4011499 [ Time Frame: Up to Week 78 ]
  • Apparent terminal half-life (t1/2) of VH4011499 [ Time Frame: Up to Week 78 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89113

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Shawn Searle

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78744

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jia Wen Chang

More Information

Sponsor

ViiV Healthcare

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Human Immunodeficiency Virus (HIV)
  • VH4011499
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Healthy participants
  • Long-Acting Injection
  • Single ascending dose
  • Multiple ascending dose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ViiV Healthcare on 2025-10-29.