A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: Male

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 Standardized Blister Model

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aristea Therapeutics, Inc.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)