The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch.
Eligible subjects will be randomly assigned to Treatment goup A, B and C. In the experiment group A, 12 subjects with a ratio of 10:2 will receive one patch of AB001 or placebo batch on Day 1 of period 1, respectively, after a wash-out period of 14 days, 10 subjects received AB001 patch will be administered with an oral capsule of active ingredient on Day 20 of period 2. In the experiment group B, 12 subjects with a ratio of 10:2 will receive two patches of AB001 or two placebo batches on Day 1 respectively, and then two patches daily from Day 8 to Day 20. In the active comparator group C, 10 subjects will receive one patch of positive comparative patch on Day 1, and then once patch every two days from Day 8 to Day 20. The tolerability, safety and pharmacokinetics of topical AB001 patch will be assessed in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
The Third People's Hospital of Wuxi
Wuxi, Jiangsu, China
Number of subjects with any adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: From baseline through Day 26
Number of subjects any serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect.
Time frame: From baseline through Day 26
Safety Assessments on Skin Reaction Evaluation
Topical Skin Reaction Score(0-2 is a better outcome): 0= no evidence of irritation 1. minimal erythema, barely perceptible 2. definite erythema, readily visible; minimal edema or minimal papular response 3. erythema and papules 4. definite edema 5. erythema, edema and papules 6. vesicular eruption 7. strong reaction spreading beyond application site
Time frame: From baseline through Day 26
pharmacokinetic parameters of AB001(Cmax)
Peak Plasma Concentration (Cmax)
Time frame: Day 1 and Day 26
pharmacokinetic parameters of AB001 (AUC)
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 and Day 26
bioavailability of AB001
To determine the bioavailability of AB001
Time frame: Day 1 and Day 26
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single and repeated dosing