Atopic Dermatitis, Psoriasis
Conditions
Brief summary
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
Interventions
DRUGYR001 Dose A on low body surface area
Part A: Single topical dose
DRUGYR001 Dose A on middle body surface area
Part A: Single topical dose
DRUGYR001 Dose A on high body surface area
Part A: Single topical dose
DRUGYR001 Dose B on low body surface area
Part A: Single topical dose
DRUGYR001 Dose B on middle body surface area
Part A: Single topical dose
DRUGYR001 Dose B on high body surface area
Part A: Single topical dose
DRUGPlacebo on low body surface area
Part A: Single topical dose
DRUGPlacebo on middle body surface area
Part A: Single topical dose
DRUGPlacebo on high body surface area
Part A: Single topical dose
DRUGYR001 Dose A on high body surface area twice daily
Part B: Multiple topical dose
DRUGYR001 Dose B on high body surface area twice daily
Part B: Multiple topical dose
DRUGPlacebo on high body surface area twice daily
Part B: Multiple topical dose
Sponsors
Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This study includes two sequential parts of single dose and multiple dose with placebo control
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent obtained from the subject 2. Male or female subject is aged between 18 and 65 years 3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2 4. Free from any clinically relevant illness or disease incl. skin disorder that may adversely affect the safety of the subject or the integrity of the study
Exclusion criteria
1. Presence or history of a clinically significant medical condition or other condition that might interfere with the safety, tolerability and PK assessment of ointment YR001, or place the subject at an unacceptable risk as a subject in this study. 2. Pregnant or lactating women. 3. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites. 4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response. 5. Have active infectious disease. 6. Subjects treated with another investigational drug, biological agent, or device 7. Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial. 8. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG. 9. Active untreated mental or psychiatric disorder. 10. Any major surgery within 6 months of screening. 11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. 13\. Drug or alcohol abuse history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Safety and Maximum Tolerate Dose (MTD) | day 0 to day 8 | Incidence of treatment related AEs (TRAEs) and local skin tolerance |
| Part B: Safety and Maximum Tolerate Dose (MTD) | day 0 to day 22 | Incidence of treatment related AEs (TRAEs) and local skin tolerance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: all treatment-emergent AEs | day 0 to day 8 | Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs) |
| Part B: all treatment-emergent AEs | day 0 to day 22 | Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs) |
Countries
United States
Outcome results
None listed