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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: Single dose of rhEGF 100mcg/ml or placebo; Drug: Multiple dose of rhEGF 100mcg/ml or placebo; Drug: Multiple dose of rhEGF 50mcg/ml or placebo; Drug: Multiple dose of rhEGF 10mcg/ml or placebo; Drug: Single dose of rhEGF 10mcg/ml or placebo; Drug: Single dose of rhEGF 50mcg/ml or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05219461

DW_EGF102OP

Details and patient eligibility

About

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

Full description

Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop

Enrollment: 48 patients

Sex: Male

Ages: 20 to 51 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Group A rhEGF 10mcg/mL

Experimental group

Description:

single dose of rhEGF 10mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)

Treatment:

Drug: Single dose of rhEGF 10mcg/ml or placebo

Group B rhEGF 50mcg/mL

Experimental group

Description:

single dose of rhEGF 50mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)

Treatment:

Drug: Single dose of rhEGF 50mcg/ml or placebo

Group C rhEGF 100mcg/mL

Experimental group

Description:

single dose of rhEGF 100mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)

Treatment:

Drug: Single dose of rhEGF 100mcg/ml or placebo

Group D rhEGF 10mcg/mL

Experimental group

Description:

multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo

Treatment:

Drug: Multiple dose of rhEGF 10mcg/ml or placebo

Group E rhEGF 50mcg/mL

Experimental group

Description:

multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo

Treatment:

Drug: Multiple dose of rhEGF 50mcg/ml or placebo

Group F rhEGF 100mcg/mL

Experimental group

Description:

multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo

Treatment:

Drug: Multiple dose of rhEGF 100mcg/ml or placebo