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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Hemay808 apply to 25%BSA | Active Comparator | 8 subjects use 1% Hemay808 |
|
| 3% Hemay808 apply to 25%BSA | Experimental | 8 subjects use 3% Hemay808 |
|
| 3% Hemay808 apply to 55%BSA | Experimental | 6 subjects use 3% Hemay808 |
|
| 7% Hemay808 apply to 25%BSA | Experimental | 8 subjects use 7% Hemay808 |
|
| placebo apply to 25%BSA | Placebo Comparator | 6 subjects use placebo apply to 25%BSA |
|
| placebo apply to 55%BSA | Placebo Comparator | 2 subjects use placebo apply to 55%BSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay808 | Drug | topical apply |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and serious adverse events. | Incidence of AEs | Day 1 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermotology hospital, Chinese academy of medical science | Nanjing | Jiangsu | 210042 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | topical apply |
|
| 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. | 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. | pre-dose, 0.5, 1, 2, 3, 5, 8, 12, 14, 24, 36, 48, 72 hours post-dose |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |