MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atopic Dermatitis
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Masking Description: Phase Ia is open label while Phase Ib is double blind.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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, us...
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.
Tracking Information
- NCT #
- NCT04815148
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon