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

Phase 1

Completed

• Conditions: Inflammatory Response
• Interventions: Drug: RIST4721; Drug: Placebo

• Registration Number: NCT04105959
• Lead Sponsor: Aristea Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Primary Completion: 2019-11-19
• Study Completion: 2019-12-09
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RIST4721 300mg	Placebo	RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.
RIST4721 300mg	RIST4721	RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.
RIST4721 150mg	Placebo	RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.
RIST4721 150mg	RIST4721	RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom