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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
41
Novartis Investigative Site
Mid Glamorgan, United Kingdom
General safety (number of subjects with adverse events)
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
Time frame: 14 days
Local skin tolerability (tolerability score)
Summarized statistics on 5-point scale tolerability scores over 14 days of treatment.
Time frame: 14 days
All parts: Amount (ng/mL) of LFX453 in plasma
Evaluate systemic steady state pharmacokinetics in human after topical administration of LFX453.
Time frame: 14 days
Part 1 and 2: LFX453 concentrations (ng/g) in the skin
LFX453 analyzed in skin.
Time frame: Day 14 and between days 18-21
All parts: LFX453 concentration (ng/mL) in urine
LFX453 analyzed in urine.
Time frame: Day 14
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LFX453 low dose cream 2
Imiquimod cream
Placebo cream 1
Placebo cream 2