Status:
TERMINATED
A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
Lead Sponsor:
Fresh Tracks Therapeutics, Inc.
Collaborating Sponsors:
Syneos Health
Innovaderm Research Inc.
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 singl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05382819
Start Date
May 16 2022
End Date
August 11 2023
Last Update
August 24 2023
Active Locations (1)
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1
Syneos Health Quebec
Montreal, Quebec, Canada, QC G1P 0A2