This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Part A: Single topical dose
Part A: Single topical dose
Part A: Single topical dose
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Part A: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Time frame: day 0 to day 8
Part B: Safety and Maximum Tolerate Dose (MTD)
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Time frame: day 0 to day 22
Part A: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Time frame: day 0 to day 8
Part B: all treatment-emergent AEs
Number, severity, causality, and outcome of all treatment-emergent AEs (TEAEs)
Time frame: day 0 to day 22
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Part A: Single topical dose
Part A: Single topical dose
Part A: Single topical dose
Part A: Single topical dose
Part A: Single topical dose
Part A: Single topical dose
Part B: Multiple topical dose
Part B: Multiple topical dose
Part B: Multiple topical dose