Topical YR001 Ointment in Adult with Mild to Moderate Atopic Dermatitis

Hangzhou Yirui Pharmaceutical Technology

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Drug: YR001 ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06309355

YR001-A03

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) at screening and Baseline.

Exclusion criteria

1. Pregnant or lactating women.
2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, 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 of skin comorbidities in the skin areas to be dosed that may interfere with study assessments 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 previous participation in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Active dose

Experimental group

Description:

The intervention is YR001 ointment on a range of body surface area for multiple topical administration

Treatment:

Drug: YR001 ointment

Placebo dose

Experimental group

Description:

The intervention is Placebo on a range of body surface area for multiple topical administration

Treatment:

Other: Placebo