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

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105959
• Other study ID #: RIST4721-102
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: June 2020
• Source: Aristea Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 9, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blister
• Inflammatory Response

Intervention

Drug:
• RIST4721
RIST4721 oral solution
• Placebo
Placebo oral solution

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Aristea Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo	Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control	Blister formation to Hour 24
Primary	Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo	Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control	Blister formation to Hour 30
Primary	Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo	Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control	Blister formation to Hour 36