Business Decision

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

This is a randomized, placebo controlled, double blind study in healthy subjects and subjects with atopic dermatitis that is designed to assess the safety and tolerability of FRTX-02 capsules at single and multiple ascending doses.

Safety will be assessed through vital signs, ECG, adverse events and safety laboratory tests.

Pharmacokinetic and pharmacodynamic information will also be collected.

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