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

NCT04105959 | Completed Phase 1

• 1 other identifier: RIST4721-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

RIST4721 300mg

EXPERIMENTAL

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

Drug: RIST4721; Drug: Placebo

RIST4721 150mg

EXPERIMENTAL

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

Drug: RIST4721; Drug: Placebo

Interventions

RIST4721 DRUG

RIST4721 oral solution

RIST4721 150mg; RIST4721 300mg

Placebo DRUG

Placebo oral solution

RIST4721 150mg; RIST4721 300mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aristea Therapeutics, Inc.: lead

Study Sites (1)

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: July 25, 2019
• Primary Completion: November 19, 2019
• Study Completion: December 9, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)