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

Phase 1

Recruiting

• Conditions: HIV Infections
• Interventions: Drug: VH4011499 Injection; Drug: Placebo for VH4011499 Injection

• Registration Number: NCT06724640
• Lead Sponsor: ViiV Healthcare

Brief Summary

The purpose of this study is to investigate safety and tolerability following single ascending subcutaneous (SC) and intramuscular (IM) doses of VH4011499 in participants without HIV. The study will also describe the pharmacokinetics following single ascending SC and IM doses of VH4011499 in participants without HIV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2024-12-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2028-08-16
• Study Completion: 2028-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.
• Male or female 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 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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
VH4011499 Active Group	VH4011499 Injection	-
VH4011499 Placebo Group	Placebo for VH4011499 Injection	-

Primary Outcome Measures

Name	Time	Method
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	Up to Week 78	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499	Up to Week 78
Maximum observed plasma concentration (Cmax) of VH4011499	Up to Week 78
Time to maximum observed plasma concentration (tmax) of VH4011499	Up to Week 78
Apparent terminal half-life (t1/2) of VH4011499	Up to Week 78

Secondary Outcome Measures

Name	Time	Method
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L])	At Day 4, Day 10, Week 4, Week 24 and Week 48
Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L)	At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Number of participants with maximum toxicity grade change from baseline in liver chemistry parameters: total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)	Baseline (Prior to Day 1) and Up to Week 78
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L])	At Day 4, Day 10, Week 4, Week 24 and Week 48
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L)	At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
Number of participants with AEs (including ISR AEs) as per severity of all grades using the DAIDS grading scale	Up to Week 78	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs and ISR AEs including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis, will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Duration of ISR (Days) AEs by grade using the DAIDS grading scale	Up to Week 78

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Las Vegas, Nevada, United States