NCT04815148

MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and PK of MH004 Topical Cream in Healthy Adult Volunteers and to Investigate Its Efficacy and Safety Profile in Participants With Atopic Dermatitis or Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Minghui Pharmaceutical Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase Ia/Ib Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis and participants with Mild to Moderate Rheumatoid Arthritis.

Detailed description

The study includes 2 parts:The first part (Phase Ia) is a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part (Phase Ib) includes two randomised, Placebo-Controlled 28-day repeated dose studies for AD and RA participants respectively, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase Ia.

Conditions

• Atopic Dermatitis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MH004 Ia(0.1%)	Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
DRUG	MH004 Ia(0.3%)	Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
DRUG	MH004 Ia(1%)	Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
DRUG	MH004 Ia(3%)	Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
DRUG	MH004 Ib-1(0.1%)	Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
DRUG	MH004 Ib-1(0.3%)	Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
DRUG	MH004 Ib-1(1%)	Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
DRUG	MH004 Ib-2(0.3%)	Spread approx. 0.5 g of MH004 topical cream to the Target Joint.
DRUG	MH004 Ib-2(1%)	Spread approx. 0.5 g of MH004 topical cream to the Target Joint.
DRUG	MH004 Ib-2(3%)	Spread approx. 0.5 g of MH004 topical cream to the Target Joint.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-03-24
• Last updated: 2021-03-24