NCT06012136

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VH4004280	VH4004280 will be administered.
DRUG	Placebo	Placebo will be administered.
DRUG	VH4011499	VH4011499 will be administered.

Timeline

• Start date: 2023-08-24
• Primary completion: 2026-06-09
• Completion: 2026-06-09
• First posted: 2023-08-25
• Last updated: 2025-09-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study