NCT05219461

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daewoong Bio Inc. · Industry
• Sex: Male
• Age: 20 Years – 51 Years
• Healthy volunteers: Accepted

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

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2019-03-29
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: South Korea