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

Primary Purpose

Inflammatory Response

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
RIST4721
Placebo
Sponsored by
Aristea Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Response

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • MAC Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RIST4721 300mg

RIST4721 150mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 23, 2019
Last Updated
June 25, 2020
Sponsor
Aristea Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04105959
Brief Title
A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristea Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIST4721 300mg
Arm Type
Experimental
Arm Description
RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover.
Arm Title
RIST4721 150mg
Arm Type
Experimental
Arm Description
RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover.
Intervention Type
Drug
Intervention Name(s)
RIST4721
Intervention Description
RIST4721 oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution
Primary Outcome Measure Information:
Title
Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo
Description
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
Time Frame
Blister formation to Hour 24
Title
Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
Description
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
Time Frame
Blister formation to Hour 30
Title
Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo
Description
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
Time Frame
Blister formation to Hour 36

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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