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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 29, 2019

Primary Completion Date

November 13, 2019

Study Completion Date

November 13, 2019

Conditions
Dry Eye Syndromes
Interventions
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

Trial Locations (1)

Unknown

Seoul National University Bundang Hospital, Seongnam-si

All Listed Sponsors
lead

Daewoong Bio Inc.

INDUSTRY

NCT05219461 - Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects | Biotech Hunter | Biotech Hunter