Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05382819
Other study ID # BBI-02-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT05579899 - Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis Phase 2
Terminated NCT04085549 - Effects of a Berry Oil Cream on Atopic Eczema and Skin N/A
Recruiting NCT05578482 - Staphylococcus Aureus and The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis Phase 4
Completed NCT03540043 - Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis Phase 2
Completed NCT03293030 - Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis Phase 4
Completed NCT03386032 - 8-Week Atopic Dermatitis (AD) Treatment Study Phase 3
Completed NCT03667014 - The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients Phase 4
Completed NCT04537468 - Development of a Method to Measure mRNA Levels in Skin Samples N/A
Completed NCT03268174 - Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis. N/A
Active, not recruiting NCT03859986 - Study in Subjects With Moderate Atopic Dermatitis Phase 2
Completed NCT04800185 - Characterizing Skin Microbiome Change in Atopic Dermatitis Early Phase 1
Completed NCT06361992 - Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children Phase 3
Recruiting NCT06024499 - Phase 2 Trial of HY209gel in Atopic Dermatitis Patients Phase 2
Recruiting NCT03742414 - Seal, Stopping Eczema and Allergy Study Phase 2
Not yet recruiting NCT06454942 - Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals N/A
Completed NCT03090178 - Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy N/A
Recruiting NCT05935085 - This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD). Phase 2
Recruiting NCT03795506 - TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE) N/A
Completed NCT01931644 - At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
Not yet recruiting NCT06469385 - Topical ENS-002 for Atopic Dermatitis in Adults Phase 1