A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers

Study Overview
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Brief Summary
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This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.

Official Title
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A Randomized, Double-blind, Placebo-controlled Single and Multiple Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Topical Ointment YR001 in Adult Healthy Volunteers

Conditions
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Atopic Dermatitis, Psoriasis

Intervention / Treatment
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* Drug: YR001 Dose A on low body surface area
* Drug: YR001 Dose A on middle body surface area
* Drug: YR001 Dose A on high body surface area
* Drug: YR001 Dose B on low body surface area
* Drug: YR001 Dose B on middle body surface area
* Drug: YR001 Dose B on high body surface area
* Drug: Placebo on low body surface area
* Drug: Placebo on middle body surface area
* Drug: Placebo on high body surface area
* Drug: YR001 Dose A on high body surface area twice daily
* Drug: YR001 Dose B on high body surface area twice daily
* Drug: Placebo on high body surface area twice daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from the subject Male or female subject is aged between 18 and 65 years Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2 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: 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. Pregnant or lactating women. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites. 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. Have active infectious disease. Subjects treated with another investigational drug, biological agent, or device Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG. Active untreated mental or psychiatric disorder. Any major surgery within 6 months of screening. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study includes two sequential parts of single dose and multiple dose with placebo control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A, Active dose A and Low body surface area<br>The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration | Drug: YR001 Dose A on low body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part A, Active dose A and Middle body surface area<br>The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration | Drug: YR001 Dose A on middle body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part A, Active dose A and High body surface area<br>The intervention is YR001 Dose A on high body surface area, low dose for single topical administration | Drug: YR001 Dose A on high body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part A, Active dose B and Low body surface area<br>The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration | Drug: YR001 Dose B on low body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part A, Active dose B and Middle body surface area<br>The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration | Drug: YR001 Dose B on middle body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part A, Active dose B and High body surface area<br>The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration | Drug: YR001 Dose B on high body surface area<br>* Part A: Single topical dose<br>|
| Placebo Comparator: Part A, Placebo and Low body surface area<br>The intervention is Placebo on low body surface area, Placebo for single topical administration | Drug: Placebo on low body surface area<br>* Part A: Single topical dose<br>|
| Placebo Comparator: Part A, Placebo and Middle body surface area<br>The intervention is Placebo on middle body surface area, Placebo for single topical administration | Drug: Placebo on middle body surface area<br>* Part A: Single topical dose<br>|
| Placebo Comparator: Part A, Placebo and High body surface area<br>The intervention is Placebo on high body surface area, Placebo for single topical administration | Drug: Placebo on high body surface area<br>* Part A: Single topical dose<br>|
| Experimental: Part B, Active dose A and High body surface area<br>The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration | Drug: YR001 Dose A on high body surface area twice daily<br>* Part B: Multiple topical dose<br>|
| Experimental: Part B, Active dose B and High body surface area<br>The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration | Drug: YR001 Dose B on high body surface area twice daily<br>* Part B: Multiple topical dose<br>|
| Placebo Comparator: Part B, Placebo and High body surface area<br>The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration | Drug: Placebo on high body surface area twice daily<br>* Part B: Multiple topical dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | day 0 to day 22 |