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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Single dose of rhEGF 10mcg/ml or placebo; Drug: Single dose of rhEGF 50mcg/ml or placebo; Drug: Single dose of rhEGF 100mcg/ml or placebo; Drug: Multiple dose of rhEGF 10mcg/ml or placebo; Drug: Multiple dose of rhEGF 50mcg/ml or placebo; Drug: Multiple dose of rhEGF 100mcg/ml or placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A rhEGF 10mcg/mL; single dose of rhEGF 10mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)	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
Experimental: Group B rhEGF 50mcg/mL; single dose of rhEGF 50mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)	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
Experimental: Group C rhEGF 100mcg/mL; single dose of rhEGF 100mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)	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
Experimental: Group D rhEGF 10mcg/mL; multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of 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
Experimental: Group E rhEGF 50mcg/mL; multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of 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
Experimental: Group F rhEGF 100mcg/mL; multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events	sign and symptoms of AE; physical exam, vital signs, ECG exam, lab test; ophthalmic exam: schirmer's test, TBUT test, slit lamp exam etc; Immunogenicity test (anti-drug antibody)	14 days from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK characteristics	Cmax in single dose administration period	14 days from baseline
PK characteristics	AUC in single dose administration period	14 days from baseline
PK characteristics	Cmax in multiple dose adminitration period	14 days from baseline
PK characteristics	AUC in multiple dose administration period	14 days from baseline
PK characteristics	Cav in multiple dose administration period	14 days from baseline

Collaborators and Investigators

• Sponsor: Daewoong Bio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: DW_EGF102OP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No