NCT05382819

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single and Multiple Ascending Doses of FRTX-02 in Healthy Subjects and Subjects With Atopic Dermatitis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Fresh Tracks Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	FRTX-02 Capsule	DYRK-1A Inhibitor
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2022-05-16
• Primary completion: 2023-02-08
• Completion: 2023-08-11
• First posted: 2022-05-19
• Last updated: 2023-08-24

Locations

1 site across 1 country: Canada