RecruitingHIV Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
Eligible age
18–55 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: ViiV Healthcare
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)
- ✓ Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.
- ✓ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06724640 · last updated 2025-10-29