Status:
COMPLETED
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Lead Sponsor:
Daewoong Bio Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
MALE
20-51 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
Key Trial Info
Start Date :
March 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05219461
Start Date
March 29 2019
End Date
November 13 2019
Last Update
February 2 2022
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea