Actively Recruiting
A Phase 1 Double-Blind, Placebo-Controlled, Randomized Study to Assess Safety, Tolerability, and Pharmacokinetics of VH4011499 in Adults Without HIV
Led by ViiV Healthcare · Updated on 2025-10-29
168
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body processes VH4011499 when given in single or multiple doses to adults without HIV. This Phase 1 trial aims to understand how the drug behaves in healthy adults aged 18 to 55 and to monitor any side effects or reactions over time. Participants will be randomly assigned to receive either a low or high dose of VH4011499 or a placebo. The drug is given by injection, either under the skin or into the muscle. Some participants will receive a single dose while others will get multiple doses. The study includes an initial dosing period and long-term follow-up extending up to 78 weeks. During the study, participants will undergo regular assessments including blood tests to measure drug levels and liver function, as well as monitoring for any side effects such as injection site reactions. Researchers will track safety over time and collect data on how the drug is absorbed and eliminated. Participation involves visits over many months to evaluate these outcomes carefully.
CONDITIONS
Brief 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...
- Be between 18 and 55 years old at the time of consent
- Be overtly healthy
- Be male or female
- Female participants must not be pregnant, not breastfeeding, and either be of nonchildbearing potential or use highly effective contraception during the study
- Be capable of giving signed informed consent
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, kidney, endocrine, blood, nervous system, or psychiatric disorders
- Abnormal blood pressure
- History of lymphoma, leukemia, or other cancers within the past 5 years except certain skin cancers
- Breast cancer within the past 10 years
- Current or chronic liver disease or abnormalities
- Clinically relevant hepatitis within the last 6 months
- Chronic hepatitis B infection
- History of allergies to study interventions
- Skin conditions interfering with injection site assessment
- Insufficient muscle for safe intramuscular injection
- High-risk behaviors increasing HIV risk
- Conditions interfering with study compliance or safety
- Use of medications within 7 days prior to dosing
- Exposure to more than 4 investigational products in the past 12 months
- Current or recent participation in another investigational study
- Positive HIV antibody/antigen test
- Elevated liver enzymes or bilirubin beyond set limits
- Reduced kidney function below specified threshold
- Regular use of tobacco, nicotine, alcohol, or drugs of abuse
- Prolonged QT interval or heart rhythm abnormalities
- Tattoos, silicone implants, or fillers at injection sites that may interfere with assessments
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 78 weeks
Participants receive either a single dose or two doses of VH4011499 or placebo via injection to assess safety, tolerability, and pharmacokinetics.
Multiple visits for dosing and assessments up to Week 78
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
E
EU GSK Clinical Trials Call Center
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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