drugset / Trial / NCT02052687

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453

NCT02052687

Phase 1 Completed 41 enrolled Novartis Pharmaceuticals
RandomizedSingle-groupTriple-blindBasic science

Summary

The purpose of this first-in human study is to demonstrate systemic and local tolerability and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy subjects. The current study has been designed with three distinct parts. Part 1 focuses on safety and tolerability of once daily application on the back, prior to moving forward and assessing the safety and tolerability in more sensitive treatment areas in Part 2 or twice daily application in Part 3.

Timeline

Start
2014-01
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Imiquimod Other / unclassified
Subject LFX453 Unknown Topical

Indications

No indication recorded.