NCT06724640

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4011499 low dose Injection	VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
DRUG	VH4011499 high dose Injection	VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
DRUG	Placebo	Placebo Injection will be administered either subcutaneously or intramuscularly.

Timeline

• Start date: 2024-12-16
• Primary completion: 2028-08-16
• Completion: 2028-08-16
• First posted: 2024-12-09
• Last updated: 2025-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study