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

NCT06724640 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 218547
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  Up to Week 78

• Area under the plasma-concentration time curve from time zero to infinity (AUC0-inf) of VH4011499 for SAD group

  Up to Week 78

• Area under the plasma concentration vs time curve (AUC0-tau) for MAD group

  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 Outcomes (11)

• Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group

  At Day 4, Day 10, Week 4, Week 24 and Week 48

• Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for MAD group

  At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52

• Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for SAD group

  At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)

• Change from baseline in liver chemistry parameters: total bilirubin and direct bilirubin (umol/L) for MAD group

  At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52 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

Study Arms (2)

Single ascending dose (SAD) Group

EXPERIMENTAL

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

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

Multiple ascending doses (MAD) Group

EXPERIMENTAL

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

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

Interventions

VH4011499 low dose Injection DRUG

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

Multiple ascending doses (MAD) Group; Single ascending dose (SAD) Group

VH4011499 high dose Injection DRUG

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

Multiple ascending doses (MAD) Group; Single ascending dose (SAD) Group

Placebo DRUG

Placebo Injection will be administered either subcutaneously or intramuscularly.

Multiple ascending doses (MAD) Group; Single ascending dose (SAD) Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Capable of giving signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (2)

GSK Investigational Site

Las Vegas, Nevada, 89113, United States

RECRUITING

GSK Investigational Site

Austin, Texas, 78744, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Injections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): August 16, 2028
• Study Completion (Estimated): August 16, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (2)