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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLM3003 | Experimental | QLM3003 Single dose |
|
| QLM3003 Placebo | Placebo Comparator | QLM3003 vehicle Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLM3003 | Drug | 1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (severity and causality) of any local and systemic adverse events | adverse events | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of QLM3003 | Cmax | 8 days |
| Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003 | AUC0-t |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| guoping Yang, doctor | The Third Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 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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| QLM3003 Placebo |
| Drug |
1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)(matching corresponding study medication) |
|
| 8 days |
| Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003 | AUC0-∞ | 8 days |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |