A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
- Conditions
- PsoriasisAtopic Dermatitis
- Interventions
- Drug: YR001 Dose A on low body surface areaDrug: YR001 Dose B on middle body surface areaDrug: YR001 Dose A on high body surface areaDrug: YR001 Dose B on low body surface areaDrug: YR001 Dose B on high body surface areaDrug: Placebo on low body surface areaDrug: Placebo on high body surface areaDrug: YR001 Dose A on high body surface area twice dailyDrug: Placebo on high body surface area twice dailyDrug: YR001 Dose A on middle body surface areaDrug: YR001 Dose B on high body surface area twice dailyDrug: Placebo on middle body surface area
- Registration Number
- NCT05718921
- Brief Summary
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
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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.
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Pregnant or lactating women.
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Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
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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.
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Have active infectious disease.
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Subjects treated with another investigational drug, biological agent, or device
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Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
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Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
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Active untreated mental or psychiatric disorder.
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Any major surgery within 6 months of screening.
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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.
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Drug or alcohol abuse history.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A, Active dose A and Low body surface area YR001 Dose A on low body surface area The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration Part A, Active dose B and Middle body surface area YR001 Dose B on middle body surface area The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration Part A, Active dose A and High body surface area YR001 Dose A on high body surface area 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 YR001 Dose B on low body surface area The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration Part A, Active dose B and High body surface area YR001 Dose B on high body surface area 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 on low body surface area The intervention is Placebo on low body surface area, Placebo for single topical administration Part A, Placebo and High body surface area Placebo on high body surface area The intervention is Placebo on high body surface area, Placebo for single topical administration Part B, Active dose A and High body surface area YR001 Dose A on high body surface area twice daily The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration Part B, Placebo and High body surface area Placebo on high body surface area twice daily The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration Part A, Active dose A and Middle body surface area YR001 Dose A on middle body surface area The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration Part B, Active dose B and High body surface area YR001 Dose B on high body surface area twice daily The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration Part A, Placebo and Middle body surface area Placebo on middle body surface area The intervention is Placebo on middle body surface area, Placebo for single topical administration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Part B: all treatment-emergent AEs day 0 to day 22 Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Part A: all treatment-emergent AEs day 0 to day 8 Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Trial Locations
- Locations (1)
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States