A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults

ViiV Healthcare

Status and phase: Active, not recruiting; Phase 1

Conditions: HIV Infections

Treatments: Drug: Placebo; Drug: VH4004280; Drug: VH4011499

Study type: Interventional

Funder types: Industry

Identifiers

NCT06012136

218306

Details and patient eligibility

About

The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.

Enrollment: 85 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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85 participants in 5 patient groups, including a placebo group

Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280

Experimental group

Description:

VH4004280 injections are administered subcutaneously (SC), SC+ rHuPH20, or intramuscularly (IM).

Treatment:

Drug: VH4004280

Part 1: Participants Receiving Placebo

Placebo Comparator group

Description:

Placebo injection is administered.

Treatment:

Drug: Placebo

Part 2 SAD: Participants Receiving VH4011499

Experimental group

Description:

VH4011499 injections are administered SC, SC+ rHuPH20, or IM.

Treatment:

Drug: VH4011499

Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499

Experimental group

Description:

VH4011499 injections are administered IM.

Treatment:

Drug: VH4011499

Part 2: Participants Receiving Placebo

Placebo Comparator group

Description:

Placebo injection is administered.

Treatment:

Drug: Placebo