A double-blind, placebo-controlled study in healthy subjects.
Research type
Research Study
Full title
First-in-human, placebo-controlled trial with LEO 142397 (capsule and intravenous formulations) in healthy subjects, including healthy Japanese subjects.
IRAS ID
255602
Contact name
Ashley Brooks
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2018-004470-10
Duration of Study in the UK
0 years, 6 months, 26 days
Research summary
LEO 142397 is a new selective JAK1 inhibitor (inhibitor of a signal for several chemicals called interleukins in the body that are important in the role of inflammation in the body which are also thought to cause atopic dermatitis (AD) and other immune related disease).
The study will be in 2 parts, there will be a single ascending dose (SAD) and a multiple ascending dose (MAD) part of the study. This will help us understand the pharmacokinetics (how the body affects the drug) and the pharmacodynamics(how the drug affects the body) and the safety and tolerability of LEO142397.
The SAD portion of the study will have 5-7 sequential dosing cohorts, one of these groups will incorporate an investigation of the effect of food and another cohort with have an intravenous (through the veins) dosing arm. A female cohort will also be added only if there are not enough females in the earlier cohorts.
The MAD portion of the study will have 3-5 sequential dose cohorts plus a Japanese cohort dosed with the highest likely therapeutic dose.
Dosing at the next dose level will require all safety data to be assessed and then discussed and agreed that it is safe to do so by general consensus from the sponsor and the research unit.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0193
Date of REC Opinion
24 May 2019
REC opinion
Favourable Opinion