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
ViiV Healthcare
268 participants
Mar 21, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
VH4524184 to be taken orally.
Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.
Starting dose of Placebo Formulation A administered subcutaneously.
Dose of rHuPH20 administered subcutaneously.
Starting dose of VH4524184 LAI Formulation B administered subcutaneously.
Starting dose of Placebo Formulation B administered subcutaneously.
Starting dose VH4524184 LAI Formulation A administered intramuscularly.
Dose of Placebo Formulation A administered intramuscularly.
Starting dose VH4524184 LAI Formulation B administered intramuscularly.
Dose of Placebo Formulation B administered intramuscularly.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06310551