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

NCT07182864 | Completed Phase 1

• 1 other identifier: MH004-CP002CN
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomization until Day 14 for MAD participants. The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.

  1 year

• Phase II: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With MH004 Ointment

  EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

  Baseline and week 4.

Secondary Outcomes (6)

• Phase I: Characterization of Pharmacokinetics (Cmax) of MH004 Ointment in Healthy Volunteers or Participants With Mild to Moderate Atopic Dermatitis

  Up to 6 Months

• Phase II: Mean Percentage Change From Baseline in EASI Score at Week 2

  Baseline, Week 2

• Percentage of Participants Who Achieve a ≥ 50% or ≥ 75% Improvement From Baseline in EASI (EASI-50 or EASI-75) at Weeks 4

  Baseline, Week 4

• Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 4

  Baseline, Week 4

• Mean Change From Baseline in the Scoring in Atopic Dermatitis at Week 4

  Baseline, Week 4

Study Arms (10)

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

EXPERIMENTAL

SAD and MAD

Drug: MH004 0.1% Ointment

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

EXPERIMENTAL

SAD and MAD

Drug: MH004 0.3% Ointment

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

EXPERIMENTAL

SAD and MAD

Drug: MH004 1.0% Ointment

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

EXPERIMENTAL

SAD and MAD

Drug: MH004 3.0% Ointment

Phase II. MH004 (0.1%) in Atopic Dermatitis

EXPERIMENTAL

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

Drug: MH004 0.1% Ointment

Phase II. MH004 (0.3%) in Atopic Dermatitis

EXPERIMENTAL

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

Drug: MH004 0.3% Ointment

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

EXPERIMENTAL

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

Drug: MH004 1.0% Ointment

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

EXPERIMENTAL

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

Drug: MH004 3.0% Ointment

Phase I. Vehicle Ointment in healthy volunteers SAD and MAD

PLACEBO COMPARATOR

SAD and MAD

Drug: Vehicle Ointment

Phase II. Vehicle Ointment in Atopic Dermatitis

PLACEBO COMPARATOR

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

Drug: Vehicle Ointment

Interventions

MH004 0.1% Ointment DRUG

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

Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD; Phase II. MH004 (0.1%) in Atopic Dermatitis

MH004 0.3% Ointment DRUG

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

Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD; Phase II. MH004 (0.3%) in Atopic Dermatitis

MH004 1.0% Ointment DRUG

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

Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis; Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD

MH004 3.0% Ointment DRUG

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

Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis; Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD

Vehicle Ointment DRUG

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

Phase I. Vehicle Ointment in healthy volunteers SAD and MAD; Phase II. Vehicle Ointment in Atopic Dermatitis

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day 1.
• Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
• Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

You may not qualify if:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• 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.
• 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.
• 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.
• Previously received Janus kinase (JAK) inhibitors, systemic or topical.
• Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
• Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin \> 1.5 × ULN.
• Pregnant or lactating participants, or those considering pregnancy.
• Alcohol or drug abuse. -

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: January 6, 2022
• Primary Completion: September 8, 2022
• Study Completion: October 8, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)