Status:
COMPLETED
MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Minghui Pharmaceutical (Hangzhou) Ltd
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
12-70 years
Phase:
PHASE1
PHASE2
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 volunt...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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. -
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07182864
Start Date
January 6 2022
End Date
October 8 2022
Last Update
September 19 2025
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China