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

Sponsor

Aristea Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04105959

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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 Standardized Blister Model

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Response	Drug: RIST4721 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Jul 25, 2019

Actual Primary Completion Date :

Nov 19, 2019

Actual Study Completion Date :

Dec 9, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: RIST4721 300mg

RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.

Drug: RIST4721

RIST4721 oral solution

Drug: Placebo

Placebo oral solution

Experimental: RIST4721 150mg

RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.

Drug: RIST4721

RIST4721 oral solution

Drug: Placebo

Placebo oral solution

Outcome Measures

Primary Outcome Measures

Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo [Blister formation to Hour 24]
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
Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo [Blister formation to Hour 30]
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
Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo [Blister formation to Hour 36]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MAC Clinical Research	Manchester		United Kingdom	M13 9NQ

Sponsors and Collaborators

Aristea Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aristea Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04105959

Other Study ID Numbers:

RIST4721-102

First Posted:

Sep 26, 2019

Last Update Posted:

Jun 29, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Blister

Study Results

No Results Posted as of Jun 29, 2020