This is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028. The safety and systemic pharmacokinetics (PK) of Hemay028 will be evaluated following topical application of Hemay808 to healthy volunteers.
There are two pre-test groups. Group1 use Hemay808 and placebo on sensitive areas. Group2 will only topical use Hemay808 on 5%BSA. After 2 pre-test group, 4 formal testing groups will start. 1% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 55%BSA; 7% Hemay808 apply to 25%BSA. First a single doses then wash-out for three days, after that subjects will applicant twice daily for 7 days to assess the local skin tolerability, and systemic PK of these treatments. Approximately 42 healthy adult volunteers will be enrolled in this study with 8- 10 volunteers each cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, China
Number of adverse events and serious adverse events.
Incidence of AEs
Time frame: Day 1 to Day 30
Cmax
Maximum observed plasma concentration.
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
Tmax
Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of maximum concentration Time of Time of maximum concentration Time of maximim plasma concentration
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUCt
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
AUC∞
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Time frame: pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose
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