EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
Trial Parameters
Brief Summary
GRWD0715 is an orally administered, selective inhibitor of the Endoplasmic Reticulum Aminopeptidase 1 \[ERAP1\] enzyme being explored as a potential new treatment for axial spondyloarthritis (axSpA), a long term condition caused by inflammation predominantly affecting the sacroiliac joints (SIJs) and spine.
Eligibility Criteria
Inclusion Criteria: Healthy Volunteers * Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit * Participant must provide written informed consent to participate in the study * Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice) * Male participants (and their female partners) / female participants must be willing to adhere to contraception requirements as detailed in the protocol * Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit * Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) / \[Height (m)\]2 AxSpA Participants * Male or female, 18-65 years of age * Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including: 1. HLA-B27 +ve (local testing) 2. Objective evidence of inflammation at screening, specifically act