EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
ConditionAxial Spondyloarthritis (AxSpA)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrey Wolf Therapeutics
About this trial
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
Qualifiers
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
Disqualifiers
History or presence of any clinically significant findings in medical history, physical examination, vital signs and/or laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study
Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and/or hepatitis B or C infection, as determined at the Screening visit
Participants who have received >1/(Australia only) >2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic drugs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.
Trial design
Treatments tested in this trial
- Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers
- Part B - Multiple Ascending Dose (MAD) in participants with axSpA
- Part C - Safety expansion cohort in participants with axSpA
- Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA
Treatment groups
141 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov