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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    129
  • sponsor
    Fresh Tracks Therapeutics, Inc.
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Updated on 15 October 2022
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Accepts healthy volunteers

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.

Details
Condition Atopic Dermatitis Eczema
Treatment Placebo, BBI-02 Capsule, FRTX-02 Capsule
Clinical Study IdentifierNCT05382819
SponsorFresh Tracks Therapeutics, Inc.
Last Modified on15 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Part 1 (SAD/MAD)
Healthy male or female
-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
-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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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