A Phase 1 interventional study of VH4011499 low dose Injection and VH4011499 high dose Injection in HIV Infections, sponsored by ViiV Healthcare. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 168 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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
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
VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
Placebo Injection will be administered either subcutaneously or intramuscularly.
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.
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
Absolute values of liver chemistry parameters: total bilirubin and direct bilirubin (micromoles per liter [umol/L]) for SAD group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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]) for SAD group
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48
Absolute values of liver chemistry parameters: ALP, AST, and ALT (International Units per Liter [IU/L]) for MAD group
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Change from Baseline in Liver Chemistry Parameters: ALP, AST, and ALT (IU/L) for SAD group
Time frame: 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: ALP, AST, and ALT (IU/L) for MAD group
Time frame: 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 Grade 1 AEs (including ISR AEs) as per severity 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.
Time frame: Week 78 post dose (Week 82 for MAD Group)
Duration of ISR (Days) AEs by grade using the DAIDS grading scale
Time frame: Week 78 post dose (Week 82 for MAD Group)
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Supporting information: Study protocol, Sap, Icf, Csr
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