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First Time in Human Study of Long Acting VH4524184 Formulations - Trial NCT06310551

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.

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NCT06310551
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06310551
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First Time in Human Study of Long Acting VH4524184 Formulations
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

Study Focus

HIV Infections

Oral VH4524184

Interventional

drug

Sponsor & Location

ViiV Healthcare

Lenexa,San Antonio, United States of America

Timeline & Enrollment

Phase 1

Mar 14, 2024

Nov 27, 2026

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 infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06310551

Non-Device Trial