A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants

NCT07818915 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 221875
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.

Conditions

HIV Infections

Keywords

Pharmacokinetics; Safety; Tolerability; Cabotegravir; VH4367310; Healthy adults

Outcome Measures

Primary Outcomes (6)

• Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB

  Up to Week 72

• Maximum observed plasma concentration (Cmax) of VH4367310 and CAB

  Up to Week 72

• Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB

  Up to Week 72

• 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.

  Up to Week 72

• Number of participants with AEs as per severity

  Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = Death.

  Up to Week 72

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

  An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.

  Up to Week 72

Other Outcomes (2)

• Number of participants with changes in ECG parameters over time

  Up to Week 72

• Number of participants with changes in laboratory parameters over time

  Up to Week 72

Study Arms (2)

VH4367310 Group

EXPERIMENTAL

Participants will be randomized to receive a single injection of VH4367310 on Day 1.

Drug: VH4367310

Placebo Group

PLACEBO COMPARATOR

Participants will be randomized to receive placebo on Day 1.

Drug: Placebo

Interventions

VH4367310 DRUG

VH4367310 will be administered intramuscularly.

VH4367310 Group

Placebo DRUG

Placebo will be administered intramuscularly.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

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: Double blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2030
• Last Updated: September 14, 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.