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This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Active dose A and Low body surface area | Experimental | The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration |
|
| Part A, Active dose A and Middle body surface area | Experimental | The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration |
|
| Part A, Active dose A and High body surface area | Experimental | The intervention is YR001 Dose A on high body surface area, low dose for single topical administration |
|
| Part A, Active dose B and Low body surface area | Experimental | The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration |
|
| Part A, Active dose B and Middle body surface area | Experimental | The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YR001 Dose A on low body surface area | Drug | Part A: Single topical dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Maximum Tolerate Dose (MTD) | Incidence of treatment related AEs (TRAEs) and local skin tolerance | day 0 to day 8 |
| Part B: Safety and Maximum Tolerate Dose (MTD) | Incidence of treatment related AEs (TRAEs) and local skin tolerance | day 0 to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: all treatment-emergent AEs | Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs) | day 0 to day 8 |
| Part B: all treatment-emergent AEs | Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
13. Drug or alcohol abuse history.
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| Name | Affiliation | Role |
|---|---|---|
| Stacy Smith, Dr. MD | Encinitas, California USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
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This study includes two sequential parts of single dose and multiple dose with placebo control
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|
| Part A, Active dose B and High body surface area | Experimental | The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration |
|
| Part A, Placebo and Low body surface area | Placebo Comparator | The intervention is Placebo on low body surface area, Placebo for single topical administration |
|
| Part A, Placebo and Middle body surface area | Placebo Comparator | The intervention is Placebo on middle body surface area, Placebo for single topical administration |
|
| Part A, Placebo and High body surface area | Placebo Comparator | The intervention is Placebo on high body surface area, Placebo for single topical administration |
|
| Part B, Active dose A and High body surface area | Experimental | The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration |
|
| Part B, Active dose B and High body surface area | Experimental | The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration |
|
| Part B, Placebo and High body surface area | Placebo Comparator | The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration |
|
| YR001 Dose A on middle body surface area | Drug | Part A: Single topical dose |
|
| YR001 Dose A on high body surface area | Drug | Part A: Single topical dose |
|
| YR001 Dose B on low body surface area | Drug | Part A: Single topical dose |
|
| YR001 Dose B on middle body surface area | Drug | Part A: Single topical dose |
|
| YR001 Dose B on high body surface area | Drug | Part A: Single topical dose |
|
| Placebo on low body surface area | Drug | Part A: Single topical dose |
|
| Placebo on middle body surface area | Drug | Part A: Single topical dose |
|
| Placebo on high body surface area | Drug | Part A: Single topical dose |
|
| YR001 Dose A on high body surface area twice daily | Drug | Part B: Multiple topical dose |
|
| YR001 Dose B on high body surface area twice daily | Drug | Part B: Multiple topical dose |
|
| Placebo on high body surface area twice daily | Drug | Part B: Multiple topical dose |
|
| day 0 to day 22 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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