A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV

NCT06652958 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 221877
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).

Conditions

HIV Infections

Keywords

Human Immunodeficiency Virus (HIV); VH4527079; Monoclonal Antibody; Safety; Pharmacokinetics (PK); Healthy Adults; Persons with HIV (PWH)

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events (AEs) of Grade 2 and above severity

  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. Severity of AEs will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.

  Up to Week 24 follow-up period

• Area under the plasma-concentration time curve from time zero to infinity (AUC 0-inf) of VH4527079

  From Day 1 Up to Week 24 follow-up period

• Area under the plasma-concentration time curve from time zero to the last quantifiable concentration (AUC 0-tlast) of VH4527079

  From Day 1 Up to Week 24 follow-up period

• Area under the plasma-concentration time curve from defined interval between doses (AUCtau) of VH4527079

  From Day 1 Up to Week 24 follow-up period

• Maximum observed plasma concentration (Cmax) of VH4527079

  From Day 1 Up to Week 24 follow-up period

• Time to maximum observed plasma concentration (Tmax) of VH4527079

  From Day 1 Up to Week 24 follow-up period

• Apparent terminal half-life (t1/2) of VH4527079

  From Day 1 Up to Week 24 follow-up period

Secondary Outcomes (39)

• AUC0-inf of VH4527079 after a single dose administered via SC route relative to IV administration

  From Day 1 Up to Week 24 follow-up period

• AUC0-tlast of VH4527079 after a single dose administered via SC route relative to IV administration

  From Day 1 Up to Week 24 follow-up period

• Cmax of VH4527079 after a single dose administered via SC route relative to IV administration

  From Day 1 Up to Week 24 follow-up period

• Post-baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin & Fasting lipid panel (milligrams per deciliter)

  From Day 1 (pre-Dose 1) Up to Week 24 follow-up period

• Post-baseline values for chemistry panels: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)

  From Day 1 (pre-Dose 1) Up to Week 24 follow-up period

Study Arms (9)

Arm A, Cohort 1

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 2

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 3

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 4

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 5

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 6

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion.

Biological: VH4527079

Arm A, Cohort 7

EXPERIMENTAL

Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection.

Biological: VH4527079

Arm B, Cohort 8

EXPERIMENTAL

Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.

Biological: VH4527079

Arm B, Cohort 9

EXPERIMENTAL

Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.

Biological: VH4527079

Interventions

VH4527079 BIOLOGICAL

VH4527079 solution for injection or infusion will be administered either by SC injection or IV infusion respectively.

Arm A, Cohort 1; Arm A, Cohort 2; Arm A, Cohort 3; Arm A, Cohort 4; Arm A, Cohort 5; Arm A, Cohort 6; Arm A, Cohort 7; Arm B, Cohort 8; Arm B, Cohort 9

Eligibility Criteria

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

You may qualify if:

• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent.
• Participants who are overtly healthy based on a 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.
• For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study).
• Body weight more than or equal to (\>=)50.0 kg for men and \>=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m\^2.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not pregnant or breastfeeding and, at least, one of the following conditions apply:
• Is not a Participant of childbearing potential (POCBP). OR
• Is a POCBP and agrees to use a highly effective contraceptive method 3 weeks prior to the start of this study and during the study.
• Capable of giving signed informed consent.
• Willing to have samples stored for future research for participants in Arm B; Cohort 8 (Healthy Volunteers) and Cohort 9 (PWH in Arm B).

You may not qualify if:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any medical condition 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.
• Weight \>115.0 kg.
• Any medical condition that is not well controlled.
• Positive HIV testing for participants enrolled in Arm A and in Arm B Cohort 8.
• Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
• The participant has an underlying skin disease or disorder, piercing, or tattoos that would interfere with assessment of injection site reactions.
• History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy.
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
• Any condition which, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
• Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease).
• Known history of cirrhosis with or without viral hepatitis co-infection.
• History of clinically relevant hepatitis within last 6 months.
• Lymphoma, leukemia, or any malignancy (except for breast cancer) 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.
• Participants who poses a significant suicidality risk.
• Any pre-existing physical or mental condition which, 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 22, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

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 terminated asset(s) 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.

Locations

US (1)