drugset / Trial / NCT04689035

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

NCT04689035 ↗

Phase 1 Completed 46 enrolled Avilex Pharma
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2020-09-27
Primary completion
2023-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject AVLX-144 Unknown — Intravenous

Indications

No indication recorded.