Evaluating a new injection for HIV treatment in healthy adults

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults

This study is testing a new injection for HIV treatment in healthy adults to see how well the body handles the medication compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: ViiV Healthcare (Industry-sponsored)
• Locations: 2 sites (Las Vegas, Nevada and 1 other locations)
• Trial ID: NCT06012136 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, tolerability, and pharmacokinetics of new capsid inhibitors administered via a single suspension injection in healthy adults. Participants will receive either the investigational drugs VH4004280 or VH4011499, or a placebo, with doses given through subcutaneous and intramuscular routes. The study aims to assess how these drugs are absorbed, metabolized, and eliminated from the body, providing crucial data for future HIV treatment options.

Who should consider this trial

Good fit: Ideal candidates are healthy adults who can provide informed consent and meet specific health criteria.

Not a fit: Patients with significant health issues or a history of certain disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective long-acting treatments for HIV.

How similar studies have performed: While there have been studies on capsid inhibitors, this specific approach is relatively novel and untested in this context.

Eligibility criteria

Inclusion Criteria:

* Participants who are overtly healthy.
* Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
* Male or female participants of non-childbearing potential.
* 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 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 capsid inhibitor intramuscular (gluteus medius) administration.
* History of or on-going high-risk behaviours that may put the participant at increased risk for HIV.
* Past or intended use of over-the-counter or prescription medication including herbal medications.
* Current enrollment or recent past participation in another investigational study.
* Exposure to more than 4 investigational products within 12 months prior to dosing.
* Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin \>1.5xULN), and/or estimated creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2).
* History of or current infection with hepatitis B or hepatitis C.
* Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission.
* Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.
* Positive HIV antibody/antigen test.
* Abnormal electrocardiogram (ECG) parameters.
* 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 (gluteal) which may interfere with interpretation of injection site reactions or administration of study product.

Where this trial is running

Las Vegas, Nevada and 1 other locations

• GSK Investigational Site — Las Vegas, Nevada, United States (Recruiting)
• GSK Investigational Site — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions HIV Infections; Healthy participants; Human Immunodeficiency Virus; VH4004280; VH4011499; Long-Acting Injection; Single ascending dose