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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A-AB001 | Experimental | Apply 1 patch of AB001 patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1. Subjects who received the AB001 patch in period 1 will then receive a single oral capsule of active ingredient on Day 20 in period 2. |
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| Treatment B-AB001 | Experimental | Apply 2 patches of AB001 patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20. |
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| Treatment C | Active Comparator | Apply 1 patch of positive comparative patch on the lower back of the subjects on either side of the spine without occlusion for 48 hours on Day 1 and then one patch every two days from Days 8 to 20. |
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| Treatment A-Placebo | Placebo Comparator | Apply 1 patch of placebo patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1. |
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| Treatment B-Placebo | Placebo Comparator | Apply 2 patches of placebo patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB001 | Drug | single and repeated dosing |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From baseline through Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments on Skin Reaction Evaluation | Topical Skin Reaction Score(0-2 is a better outcome): 0= no evidence of irritation
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frontier clinical team | Frontier Biotechnologies Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third People's Hospital of Wuxi | Wuxi | Jiangsu | 214041 | China |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| oral capsule | Drug | single dose |
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| positive comparative patch | Drug | single and repeated dosing |
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| Placebos | Drug | single and repeated dosing |
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| From baseline through Day 26 |
| pharmacokinetic parameters of AB001(Cmax) | Peak Plasma Concentration (Cmax) | Day 1 and Day 26 |
| pharmacokinetic parameters of AB001 (AUC) | Area under the plasma concentration versus time curve (AUC) | Day 1 and Day 26 |
| bioavailability of AB001 | To determine the bioavailability of AB001 | Day 1 and Day 26 |