NCT07182864

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

Phase I/II Study of MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
DRUG	MH004 0.1% Ointment	MH004 0.1% ointment applied topically to the affected area as a thin film.
DRUG	MH004 0.3% Ointment	MH004 0.3% ointment applied topically to the affected area as a thin film.
DRUG	MH004 1.0% Ointment	MH004 1.0% ointment applied topically to the affected area as a thin film.
DRUG	MH004 3.0% Ointment	MH004 3.0% ointment applied topically to the affected area as a thin film.
DRUG	Vehicle Ointment	Matching vehicle ointment applied topically to the affected area as a thin film.

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-09-08
• Completion: 2022-10-08
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China