Actively Recruiting
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
Led by ViiV Healthcare · Updated on 2025-10-29
168
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Female participants must not be pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed during the study.
- Female participants of childbearing potential must use a highly effective method of contraception through 78 weeks after the last dose or through the end of the study.
- Participant must be capable of giving signed informed consent.
You will not qualify if you...
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders that may affect drug metabolism, pose risk, or interfere with data.
- Abnormal blood pressure.
- History of lymphoma, leukemia, or any cancer within past 5 years except certain skin cancers without metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Current or chronic liver disease or known hepatic or biliary abnormalities.
- Clinically relevant hepatitis within last 6 months.
- Chronic hepatitis B infection.
- History of sensitivity or allergy to study interventions.
- Underlying skin disease interfering with injection site assessment.
- Insufficient muscle mass for safe intramuscular injection.
- History or ongoing high-risk behaviors increasing HIV risk.
- Any condition impairing ability to comply with dosing or protocol.
- Use of any medication within 7 days prior to dosing.
- Exposure to more than 4 new investigational products within 12 months before dosing.
- Current or recent participation in another investigational study.
- Positive HIV antibody/antigen test.
- Elevated liver enzymes or bilirubin beyond specified limits, or low kidney function.
- Regular use of tobacco, nicotine products, alcohol, or drugs of abuse.
- QTcF interval greater than 450 msec.
- Evidence of heart attack, conduction abnormalities, arrhythmias, or certain pauses.
- Tattoos, skin conditions, or silicone implants at injection sites that interfere with assessment or administration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
Las Vegas, Nevada, United States, 89113
Actively Recruiting
2
GSK Investigational Site
Austin, Texas, United States, 78744
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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