New injectable HIV prevention drug tested in healthy volunteers
NCT ID NCT07822477
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing a new injectable drug called VH5356136 to see if it is safe and how the body processes it. The trial enrolls about 160 healthy adults without HIV, ages 18 to 55. Participants receive a single dose of the drug or a placebo, and researchers monitor side effects and measure drug levels in the blood over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental injectable drug called VH5356136
- What this could lead to
- If it works, this could lead to a long-acting injectable option for preventing HIV.
- What could go wrong
- This is a small, early-stage trial in healthy volunteers. The drug may cause side effects or not stay in the body long enough to be useful, and it may never reach the market.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF). * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. * Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive). * Participants of any sex (male or female) are eligible. A female participant (female sex assigned at birth) is eligible to participate if they are a person of non-childbearing potential (PONCBP). * Capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. The criteria presented above represent a subset of the key inclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol. Exclusion Criteria: * History or presence of, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological 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. * History of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates study participation. * History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. * Any preexisting physical or mental condition which, in the opinion of the investigator or the medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Previous exposure to the parent molecule VH4524184. * Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study. * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention. * Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication. * Current enrolment or participation in another clinical study. * Any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound. * Positive HIV antibody/antigen test. * History of clinically relevant hepatitis within the last 6 months. * Positive hepatitis B or hepatitis C test. * Clinically significant cardiovascular disease.. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec) and \>480 msec (bundle branch block). * Blood pressure (BP) \>140/90 (systolic BP/diastolic BP \[SBP/DBP\]). * Resting heart rate (HR) \<50 or \>100 beats per minute (bpm) when vital signs are measured at Screening or Check-in. The criteria presented above represent a subset of the key exclusion criteria for the study. Additional criteria, restrictions, and eligibility requirements may apply as specified in the study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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