Topical YR001 Ointment in Adult with Mild to Moderate Atopic Dermatitis

Last updated: March 20, 2025
Sponsor: Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Hives (Urticaria)

Allergy

Treatment

YR001 ointment

Placebo

Clinical Study ID

NCT06309355
YR001-A03
  • Ages > 18
  • All Genders

Study Summary

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent obtained from the subject.

  2. Male or female subject is aged 18 or older.

  3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.

  4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) atscreening and Baseline.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women.

  2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UVexposure, at the possible IP application sites.

  3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).

  4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence ofskin comorbidities in the skin areas to be dosed that may interfere with studyassessments and treatment response.

  5. Participation in another interventional clinical trial (e.g. investigational drug,biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previousparticipation in this clinical trial.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: YR001 ointment
Phase: 2
Study Start date:
June 19, 2024
Estimated Completion Date:
December 20, 2025

Connect with a study center

  • Encore Medical Research -Boynton Beach

    Boynton Beach, Florida 33436
    United States

    Active - Recruiting

  • Encore Medical Research-Hollywood

    Hollywood, Florida 33331
    United States

    Active - Recruiting

  • Encore Medical Research-Weston

    Weston, Florida 33331
    United States

    Active - Recruiting

  • DelRicht Research

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

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