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

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

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Response
• Intervention / Treatment: Drug: Placebo; Drug: RIST4721

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9NQ
    • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIST4721 300mg; RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.	Drug: Placebo; Placebo oral solution; Drug: RIST4721; RIST4721 oral solution
Experimental: RIST4721 150mg; RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.	Drug: Placebo; Placebo oral solution; Drug: RIST4721; RIST4721 oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Aristea Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister
• Other Study ID Numbers: RIST4721-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No