Clinical trial NCT05382819: A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Atopic Dermatitis Eczema
Lead sponsor: Fresh Tracks Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Innovaderm Research Inc.
First posted: 2022-05-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The number of participants with treatment-emergent adverse events.
timeFrame: Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Syneos Health Quebec
state: Quebec
Study officials:
References: