New injectable HIV prevention candidate tested for safety

NCT ID NCT07818915

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing an experimental injectable drug called VH4367310 in healthy adults aged 18 to 55. The drug is a long-acting form of cabotegravir, a medicine already used to prevent HIV. This phase 1 trial gives a single increasing dose to measure how the body processes the drug and to check for side effects. The goal is to see if this formulation is safe and tolerable before larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VH4367310, an experimental long-acting cabotegravir prodrug given as an intramuscular injection
What this could lead to
If it works, this could lead to a longer-lasting injectable option for preventing HIV, possibly needing fewer doses per year.
What could go wrong
This is a first-in-human, phase 1 study with 112 healthy volunteers. It mainly checks safety and drug levels, not whether it prevents HIV. Many early candidates fail or cause side effects.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Participant must be greater than or equal to (\>=) 18 years and less than or equal to (\<=) 55 years of age, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation. * Body weight \>=40 kg and BMI within the range \>=18 to \<=32 kg/m\^2. * Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during the study intervention period and for at least 90 days after the last dose of study intervention. Participants assigned female at birth are eligible to participate if they are a participant of non-childbearing potential (PONCBP). * Capable of giving written informed consent. Exclusion Criteria: * Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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. * 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. * Unstable liver disease or known hepatic or biliary abnormalities. * History of clinically relevant hepatitis within last 6 months. * History of cirrhosis with or without viral hepatitis co-infection. * Participants determined by the investigator to have a high risk of seizures. * Participant who poses a significant suicidality risk. * Current or anticipated need for chronic anti-coagulation therapy. * Hereditary coagulation or platelet disorders. * Any acute laboratory abnormality at screening that would preclude participation or exclusionary laboratory value. * Abnormal blood pressure. * ALT \>1.5x upper limit of normal (ULN). Total bilirubin \>1.5x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5x ULN as long as direct bilirubin is \<=1.5x ULN. * Hemoglobin \<12.5 g/dL for men and \<11 g/dL for women. * Creatinine clearance (eGFR) of \<60 millilitre per minute (mL/min)/1.73 square meter (m\^2). * Presence of HbsAg and/or HbcAb at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. * Positive HIV antibody/antigen test (HIV-1 ± HIV-2). * Current enrolment or past participation in another investigational study in which an experimental drug or experimental vaccine was administered. * Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication. * Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Past participation in another investigational clinical study in which long-acting CAB was administered or any CAB use for pre-exposure prophylaxis (PrEP). * History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or another allergy. * Participant has an implant/enhancement (including fillers); or tattoo or other dermatological condition overlying the area for IM or SC injection or any other area which may significantly interfere with interpretation of injection site reactions. * History of or ongoing high-risk behaviors that may put the participant at increased risk for HIV. * Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females. * Regular use of known drugs of abuse. * Positive pre-study drug/alcohol screen. * Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

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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.

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