Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects

Study Overview
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Brief Summary
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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

Detailed Description
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Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Single dose of rhEGF 10mcg/ml or placebo
* Drug: Single dose of rhEGF 50mcg/ml or placebo
* Drug: Single dose of rhEGF 100mcg/ml or placebo
* Drug: Multiple dose of rhEGF 10mcg/ml or placebo
* Drug: Multiple dose of rhEGF 50mcg/ml or placebo
* Drug: Multiple dose of rhEGF 100mcg/ml or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged from 20 to 51 at screening test Weight 50kg  100kg BMI 18-27 Those who are fully understood, voluntarily decided to participate and signed prior to screening Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc Exclusion Criteria: Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A rhEGF 10mcg/mL<br>single dose of rhEGF 10mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) | Drug: Single dose of rhEGF 10mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|
| Experimental: Group B rhEGF 50mcg/mL<br>single dose of rhEGF 50mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) | Drug: Single dose of rhEGF 50mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|
| Experimental: Group C rhEGF 100mcg/mL<br>single dose of rhEGF 100mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily) | Drug: Single dose of rhEGF 100mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|
| Experimental: Group D rhEGF 10mcg/mL<br>multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo | Drug: Multiple dose of rhEGF 10mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|
| Experimental: Group E rhEGF 50mcg/mL<br>multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo | Drug: Multiple dose of rhEGF 50mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|
| Experimental: Group F rhEGF 100mcg/mL<br>multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo | Drug: Multiple dose of rhEGF 100mcg/ml or placebo<br>* 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events | sign and symptoms of AE physical exam, vital signs, ECG exam, lab test ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc Immunogenicity test (anti-drug antibody) | 14 days from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK characteristics | Cmax in single dose administration period | 14 days from baseline | 
| PK characteristics | AUC in single dose administration period | 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 |