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OpenTrials
Completed

NCT Number: NCT04105959

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

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Key information

Conditions

Inflammatory Response

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RIST4721

Drug

RIST4721 oral solution

Placebo

Drug

Placebo oral solution

Primary outcomes

  1. Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo

    Time frame: 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

  2. Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo

    Time frame: 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

  3. Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aristea Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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