NCT06310551

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Oral VH4524184	VH4524184 to be taken orally.
DRUG	VH4524184 Formulation A SC	Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.
DRUG	Placebo Formulation A SC	Starting dose of Placebo Formulation A administered subcutaneously.
DRUG	rHuPH20	Dose of rHuPH20 administered subcutaneously.
DRUG	VH4524184 Formulation B SC	Starting dose of VH4524184 LAI Formulation B administered subcutaneously.
DRUG	Placebo Formulation B SC	Starting dose of Placebo Formulation B administered subcutaneously.
DRUG	VH4524184 Formulation A IM	Starting dose VH4524184 LAI Formulation A administered intramuscularly.
DRUG	Placebo Formulation A IM	Dose of Placebo Formulation A administered intramuscularly.
DRUG	VH4524184 Formulation B IM	Starting dose VH4524184 LAI Formulation B administered intramuscularly.
DRUG	Placebo Formulation B IM	Dose of Placebo Formulation B administered intramuscularly.

Timeline

• Start date: 2024-03-21
• Primary completion: 2028-01-21
• Completion: 2028-01-21
• First posted: 2024-03-15
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study