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

Atopic Dermatitis Eczema Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05382819
• Other study ID #: BBI-02-101
• Status: Terminated
• Phase: Phase 1
• Start date: May 16, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: August 2023
• Source: Fresh Tracks Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: August 11, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• FRTX-02 Capsule
DYRK-1A Inhibitor
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Canada	Syneos Health Quebec	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Fresh Tracks Therapeutics, Inc.	Innovaderm Research Inc., Syneos Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with treatment-emergent adverse events.	Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results.	Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)