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

• Status: Completed
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Bio Inc.

Criteria

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)