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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Page 1 of 1 (1 locations)

1

MAC Clinical Research

Manchester, United Kingdom, M13 9NQ

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