A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV

NCT07822477 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 300862
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections

Keywords

VH5356136; VH4524184; Safety; Tolerability; HIV; Parenteral administration; Pharmacokinetics; Ascending Dose

Outcome Measures

Primary Outcomes (11)

• Number of participants with drug-related adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A drug-related AE is an AE that, in the opinion of the investigator, is related to one of the study interventions.

  From Day 1 to Month 18

• Number of participants with Grade 2 to Grade 5 AEs

  The grading of AEs is performed based on the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale, here Grade 2 = moderate, Grade 3=severe, Grade 4 = potentially life-threatening, Grade 5 = death.

  From Day 1 to Month 18

• Number of participants with serious adverse events (SAEs)

  An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.

  From Day 1 to Month 18

• Area under the concentration time curve from zero (pre-dose) to the last quantifiable concentration (post dose) (AUC[0-tlast]) for VH5356136

  From Day 1 (pre-dose) up to Month 18 post-dose

• AUC(0-tlast) for VH4524184

  From Day 1 (pre-dose) up to Month 18 post-dose

• Maximum plasma concentration (Cmax) for VH5356136

  From Day 1 (pre-dose) up to Month 18 post-dose

• Cmax for VH4524184

  From Day 1 (pre-dose) up to Month 18 post-dose

• Time to maximum observed plasma drug concentration (tmax) for VH5356136

  From Day 1 (pre-dose) up to Month 18 post-dose

• Tmax for VH4524184

  From Day 1 (pre-dose) up to Month 18 post-dose

• Terminal half-life (t1/2) for VH5356136

  From Day 1 (pre-dose) up to Month 18 post-dose

• t1/2 for VH4524184

  From Day 1 (pre-dose) up to Month 18 post-dose

Secondary Outcomes (1)

• Number of participants with Grade 3 and Grade 4 laboratory abnormalities

  From Day 1 (pre-dose) up to Month 18 post-dose

Study Arms (4)

VH5356136 Formulation 1

EXPERIMENTAL

Participants will receive a single dose of VH5356136 Formulation 1 administered on Day 1.

Drug: VH5356136 Formulation 1

Placebo for VH5356136 Formulation 1

PLACEBO COMPARATOR

Participants will receive a single dose of placebo for VH5356136 Formulation 1 administered on Day 1.

Drug: Placebo for VH5356136 Formulation 1

VH5356136 Formulation 2

EXPERIMENTAL

Participants will receive a single dose of VH5356136 Formulation 2 administered on Day 1.

Drug: VH5356136 Formulation 2

Placebo for VH5356136 Formulation 2

PLACEBO COMPARATOR

Participants will receive a single dose of placebo for VH5356136 Formulation 2 administered on Day 1.

Drug: Placebo for VH5356136 Formulation 2

Interventions

VH5356136 Formulation 1 DRUG

Participants will receive VH5356136 Formulation 1 on Day 1.

VH5356136 Formulation 1

VH5356136 Formulation 2 DRUG

Participants will receive VH5356136 Formulation 2 on Day 1.

VH5356136 Formulation 2

Placebo for VH5356136 Formulation 1 DRUG

Participants will receive placebo for VH5356136 Formulation 1 on Day 1.

Placebo for VH5356136 Formulation 1

Placebo for VH5356136 Formulation 2 DRUG

Participants will receive placebo for VH5356136 Formulation 2 on Day 1.

Placebo for VH5356136 Formulation 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ViiV Healthcare: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blind (sponsor-unblinded) study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Groups in a Parallel Design

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): May 9, 2029
• Study Completion (Estimated): May 9, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.