Status:
COMPLETED
A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
Lead Sponsor:
Aristea Therapeutics, Inc.
Conditions:
Inflammatory Response
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardi...
Eligibility Criteria
Inclusion
- Subject is male, with Fitzpatrick skin types 1 to 3
- Subject is aged between 18 to 55 years, inclusive
- Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- Healthy as determined by a responsible physician, based on medical evaluation
- Must be willing to use birth control as indicated
Exclusion
- Subject is known to have immune deficiency or is immunocompromised
- Subject has had a recent acute infection or chronic infection
- Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug
- Clinically relevant history of abnormal physical or mental health (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04105959
Start Date
July 25 2019
End Date
December 9 2019
Last Update
June 29 2020
Active Locations (1)
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1
MAC Clinical Research
Manchester, United Kingdom, M13 9NQ