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

Aristea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Inflammatory Response

Treatments: Drug: Placebo; Drug: RIST4721

Study type: Interventional

Funder types: Industry

Identifiers

NCT04105959

RIST4721-102

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 2 patient groups

RIST4721 300mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: RIST4721

RIST4721 150mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: RIST4721