NCT04783545

Phase I Study of VLX-1005 in Healthy Subjects

A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous VLX-1005 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Veralox Therapeutics · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration. Other exploratory objectives are: To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VLX-1005	VLX-1005 infusion
DRUG	Placebo	Placebo infusion

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2021-03-05
• Last updated: 2022-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study