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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04105959

Enrollment

Registered

2019-09-26

Start date

2019-07-25

Completion date

2019-12-09

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response

Brief summary

Interventions

DRUGRIST4721

RIST4721 oral solution

DRUGPlacebo

Placebo oral solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026