VH4011499 low dose Injection
DrugVH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
NCT Number: NCT06724640
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Las Vegas, Nevada, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Up to Week 78
Time frame: Up to Week 78
Time frame: Up to Week 78
Time frame: Up to Week 78
Time frame: Up to Week 78
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
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)
Time frame: Baseline (Prior to Day 1) and Up to Week 78
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48
Time frame: At Day 4, Day 10, Day 29, Day 32, Day 38, Week 24 and Week 52
Time frame: At Day 4, Day 10, Week 4, Week 24 and Week 48 compared to Baseline (Prior to Day 1)
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)
Time frame: Week 78 post dose (Week 82 for MAD Group)
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)
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
ViiV Healthcare
Industry
A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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