NCT06310551

First Time in Human Study of Long Acting VH4524184 Formulations

Name: Clinical Trial NCT06310551
Creator: ViiV Healthcare
Keywords: HIV Infections, Oral VH4524184, Phase 1, drug, clinical trial, United States of America

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults

ViiV Healthcare·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: HIV Infections
Drug/Device/Intervention: Oral VH4524184
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: ViiV Healthcare
Location: Lenexa,San Antonio, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Mar 14, 2024
End date: Nov 27, 2026
Enrollment: 72 participants

Primary outcome

Percentage of participants reporting AEs and related AEs,Percentage of participants with AEs by severity,Percentage of participants discontinuing the treatment due to AEs,Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184,Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184,Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184,Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase),Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin),Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio),Percentage of participants reporting injection site reaction (ISR) AEs,Duration of injection site reaction AEs,Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration,Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration,Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration,Cmax of LAI VH4524184 following multiple dose administration,Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration,Tmax of LAI VH4524184 following multiple dose administration,Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration,t1/2 of LAI VH4524184 following multiple dose administration

Summary

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

ICD-10 classifications

HIV disease resulting in other viral infectionsHIV disease resulting in other bacterial infectionsHIV disease resulting in multiple infectionsAcute HIV infection syndromeHIV disease resulting in other infectious and parasitic diseases

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06310551
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06310551 through Pure Global AI's free database. This Phase 1 trial is sponsored by ViiV Healthcare and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 72 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.