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

Phase 1

Completed

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

• Registration Number: NCT05219461
• Lead Sponsor: Daewoong Bio Inc.

Brief 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

Study Timeline

• Study Start: 2019-03-29
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Study First Submitted: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B rhEGF 50mcg/mL	Single dose of rhEGF 50mcg/ml or placebo	single dose of rhEGF 50mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Group E rhEGF 50mcg/mL	Multiple dose of rhEGF 50mcg/ml or placebo	multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
Group C rhEGF 100mcg/mL	Single dose of rhEGF 100mcg/ml or placebo	single dose of rhEGF 100mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Group D rhEGF 10mcg/mL	Multiple dose of rhEGF 10mcg/ml or placebo	multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
Group A rhEGF 10mcg/mL	Single dose of rhEGF 10mcg/ml or placebo	single dose of rhEGF 10mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily)
Group F rhEGF 100mcg/mL	Multiple dose of rhEGF 100mcg/ml or placebo	multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	14 days from baseline	* 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)

Secondary Outcome Measures

Name	Time	Method
PK characteristics	14 days from baseline	Cav in multiple dose administration period

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of