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A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A rhEGF 10mcg/mL | Experimental | single dose of rhEGF 10mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
|
| Group B rhEGF 50mcg/mL | Experimental | single dose of rhEGF 50mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
|
| Group C rhEGF 100mcg/mL | Experimental | single dose of rhEGF 100mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) |
|
| Group D rhEGF 10mcg/mL | Experimental | multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo |
|
| Group E rhEGF 50mcg/mL | Experimental | multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of rhEGF 10mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events |
| 14 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PK characteristics | Cmax in single dose administration period | 14 days from baseline |
| PK characteristics | AUC in single dose administration period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
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| Group F rhEGF 100mcg/mL | Experimental | multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo |
|
| Single dose of rhEGF 50mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| Single dose of rhEGF 100mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| Multiple dose of rhEGF 10mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| Multiple dose of rhEGF 50mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| Multiple dose of rhEGF 100mcg/ml or placebo | Drug | 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo |
|
| 14 days from baseline |
| PK characteristics | Cmax in multiple dose adminitration period | 14 days from baseline |
| PK characteristics | AUC in multiple dose administration period | 14 days from baseline |
| PK characteristics | Cav in multiple dose administration period | 14 days from baseline |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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