NCT05393271

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4011499 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.

Conditions

• HIV Infections

Interventions

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

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2022-05-26
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study