MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis

NCT ID: NCT07182864

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-10-08

Brief Summary

This is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis.

Detailed Description

The study includes 2 parts: The first part (Phase I) is the first-in-human trial of MH004, consisting of a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part is a multi-center, randomized, double-Blind, vehicle-controlled phase II study to evaluate the safety, tolerability and PK of MH004 Ointment for AD participants, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase I.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD

SAD and MAD

Group Type: EXPERIMENTAL

MH004 0.1% Ointment

Intervention Type: DRUG

MH004 0.1% ointment applied topically to the affected area as a thin film.

Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD

SAD and MAD

Group Type: EXPERIMENTAL

MH004 0.3% Ointment

Intervention Type: DRUG

MH004 0.3% ointment applied topically to the affected area as a thin film.

Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD

SAD and MAD

Group Type: EXPERIMENTAL

MH004 1.0% Ointment

Intervention Type: DRUG

MH004 1.0% ointment applied topically to the affected area as a thin film.

Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD

SAD and MAD

Group Type: EXPERIMENTAL

MH004 3.0% Ointment

Intervention Type: DRUG

MH004 3.0% ointment applied topically to the affected area as a thin film.

Phase II. MH004 (0.1%) in Atopic Dermatitis

28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis

Group Type: EXPERIMENTAL

MH004 0.1% Ointment

Intervention Type: DRUG

MH004 0.1% ointment applied topically to the affected area as a thin film.

Phase II. MH004 (0.3%) in Atopic Dermatitis

28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis

Group Type: EXPERIMENTAL

MH004 0.3% Ointment

Intervention Type: DRUG

MH004 0.3% ointment applied topically to the affected area as a thin film.

Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis

28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis

Group Type: EXPERIMENTAL

MH004 1.0% Ointment

Intervention Type: DRUG

MH004 1.0% ointment applied topically to the affected area as a thin film.

Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis

28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis

Group Type: EXPERIMENTAL

MH004 3.0% Ointment

Intervention Type: DRUG

MH004 3.0% ointment applied topically to the affected area as a thin film.

Phase I. Vehicle Ointment in healthy volunteers SAD and MAD

SAD and MAD

Group Type: PLACEBO_COMPARATOR

Vehicle Ointment

Intervention Type: DRUG

Matching vehicle ointment applied topically to the affected area as a thin film.

Phase II. Vehicle Ointment in Atopic Dermatitis

28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis

Group Type: PLACEBO_COMPARATOR

Vehicle Ointment

Intervention Type: DRUG

Matching vehicle ointment applied topically to the affected area as a thin film.

Interventions

MH004 0.1% Ointment

MH004 0.1% ointment applied topically to the affected area as a thin film.

Intervention Type: DRUG

MH004 0.3% Ointment

MH004 0.3% ointment applied topically to the affected area as a thin film.

Intervention Type: DRUG

MH004 1.0% Ointment

MH004 1.0% ointment applied topically to the affected area as a thin film.

Intervention Type: DRUG

MH004 3.0% Ointment

MH004 3.0% ointment applied topically to the affected area as a thin film.

Intervention Type: DRUG

Vehicle Ointment

Matching vehicle ointment applied topically to the affected area as a thin film.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Phase I: Adults, age 18 - 70 years old, inclusive. Phase II: Adolescents aged ≥ 12 to 17 years, inclusive. Adults, age 18 - 70 years old, inclusive, at time of screening.

2. Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day 1.

3. Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.

4. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

-

Exclusion Criteria

1. Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.

2. Concurrent conditions and history of other diseases:

• Immunocompromised.
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
• Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
• Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
• Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
• Other types of eczema.

3. Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.

4. Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.

5. Previously received Janus kinase (JAK) inhibitors, systemic or topical.

6. Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.

7. Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.

8. Pregnant or lactating participants, or those considering pregnancy.

9. Alcohol or drug abuse. -

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minghui Pharmaceutical (Hangzhou) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

MH004-CP002CN

Identifier Type: -

Identifier Source: org_study_id