A Safety, Tolerability and Preliminary Efficacy Study of BBI-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

BBI-02 is an orally-available, potent and selective DYRK1A inhibitor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brickell Biotech, Inc.
• Collaborators: Innovaderm Research Inc.; Syneos Health

Criteria

Selected Inclusion Criteria

Part 1 (SAD/MAD)

• Healthy male or female

• 18-55 years of age, inclusive

• At least 50 kg in weight (males) and 45 kg in weight (females)

• BMI 18.5-30.0 kg/m2, inclusive

Part 2 (Subjects with AD)

• Male or female with atopic dermatitis

• 18-65 years of age, inclusive

• BMI 18-40.0 kg/m2, inclusive

• Validated Investigator's Global Assessment (vIGA-AD) score of ≥ 3 (moderate)

• Body surface area (BSA) with AD involvement ≥ 10%

• History of inadequate response to treatment with topical medications (e.g., corticosteroids, calcineurin inhibitors, etc.) or subjects for whom topical treatments are otherwise medically inadvisable.

Selected Exclusion Criteria

Part 1 (SAD/MAD)

• Use of tobacco products within 3 months prior to drug administration

• History of alcohol abuse or drug abuse

• Positive urine drug screen, alcohol breath test, or urine cotinine test

• Participation in a clinical research study involving the administration of an investigational or marketed drug within 30 days prior to drug administration

• Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.

Part 2 (Subjects with AD)

• History of alcohol abuse or drug abuse

• Positive urine drug screen, alcohol breath test, or urine cotinine test

• Participation in a clinical research study involving the administration of an investigational or marketed drug within 12 weeks prior to drug administration