NCT07822477Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Randomized, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Parenterally Administered VH5356136 in Adult Participants Without HIV
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 10 Sept 2026
- Start date
- 6 Nov 2026
- Primary completion date
- 9 May 2029
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT07822477
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 6 Nov 2026 to the primary completion date, 9 May 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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..
- 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.
Lab values
- 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.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec) and \>480 msec (bundle branch block).
Other
- Current enrolment or participation in another clinical study.
- Blood pressure (BP) \>140/90 (systolic BP/diastolic BP \[SBP/DBP\]).
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.