Dry Eye Syndromes
Conditions
Brief summary
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
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
Interventions
DRUGSingle dose of rhEGF 10mcg/ml or placebo
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
DRUGSingle dose of rhEGF 50mcg/ml or placebo
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
DRUGSingle dose of rhEGF 100mcg/ml or placebo
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
DRUGMultiple dose of rhEGF 10mcg/ml or placebo
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
DRUGMultiple dose of rhEGF 50mcg/ml or placebo
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
DRUGMultiple dose of rhEGF 100mcg/ml or placebo
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Sponsors
Daewoong Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 51 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | 14 days from baseline | * 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK characteristics | 14 days from baseline | Cmax in single dose administration period |
Countries
South Korea
Outcome results
None listed