Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD0284 in Healthy Subjects
Status:
Completed
Trial end date:
2017-05-30
Target enrollment:
Participant gender:
Summary
Plaque psoriasis vulgaris is a chronic inflammatory skin disorder, affecting 1-3% of the
population in Europe and the United States of America (USA) and represents one of the most
prevalent immune inflammatory diseases. AZD0284 is a potent selective inverse agonist of
RORg, which is being developed for the management of psoriasis. The current Phase 1 study
investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic
(PD) properties of single and repeated doses of AZD0284. The study will be conducted in
healthy subjects. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD), with
Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The results from this study
will form the basis for decisions on future studies. The study will help to identify
appropriate, well-tolerated doses that can be administered in subsequent studies in patients
with psoriasis.