A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
Phase 1
Terminated
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- Drug: FRTX-02 CapsuleDrug: Placebo
- Registration Number
- NCT05382819
- Lead Sponsor
- Fresh Tracks Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1B Multiple Ascending Dose (MAD) - Active FRTX-02 Capsule Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active FRTX-02 Capsule FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis. Part 1A Single Ascending Dose (SAD) - Placebo Placebo Matching placebo will be administered to healthy volunteers. Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo Placebo Matching placebo will be administered daily for 28 days to healthy volunteers. Part 1A Single Ascending Dose (SAD) - Active FRTX-02 Capsule Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. Part 1B Multiple Ascending Dose (MAD) - Placebo Placebo Matching placebo will be administered to healthy volunteers.
- Primary Outcome Measures
Name Time Method The number of participants with treatment-emergent adverse events. Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2) Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Syneos Health Quebec
🇨🇦Montréal, Quebec, Canada