NCT04689035

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Avilex Pharma · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.

Conditions

• Safety Issues
• Tolerance

Interventions

Type	Name	Description
DRUG	AVLX-144	Test drug
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-09-27
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2020-12-30
• Last updated: 2023-07-20

Locations

1 site across 1 country: Finland