Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
NCT ID: NCT05219461
Last Updated: 2022-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2019-03-29
2019-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Group A rhEGF 10mcg/mL
single dose of rhEGF 10mcg/mL eye drop or single dose of placebo
\*single dose means daily dose (administration twice daily)
Single 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
Group B rhEGF 50mcg/mL
single dose of rhEGF 50mcg/mL eye drop or single dose of placebo
\*single dose means daily dose (administration twice daily)
Single 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
Group C rhEGF 100mcg/mL
single dose of rhEGF 100mcg/mL eye drop or single dose of placebo
\*single dose means daily dose (administration twice daily)
Single 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
Group D rhEGF 10mcg/mL
multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
Multiple 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
Group E rhEGF 50mcg/mL
multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
Multiple 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
Group F rhEGF 100mcg/mL
multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
Multiple 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
Interventions
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Single 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
Single 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
Single 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
Multiple 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
Multiple 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
Multiple 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
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
51 Years
MALE
Yes
Sponsors
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Daewoong Bio Inc.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Countries
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Other Identifiers
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DW_EGF102OP
Identifier Type: -
Identifier Source: org_study_id
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