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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219461
• Other study ID #: DW_EGF102OP
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2019
• Est. completion date: November 13, 2019

Study information

• Verified date: January 2022
• Source: Daewoong Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 51 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Syndromes

Intervention

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
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Bio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK characteristics	Cmax in single dose administration period	14 days from baseline
Secondary	PK characteristics	AUC in single dose administration period	14 days from baseline
Secondary	PK characteristics	Cmax in multiple dose adminitration period	14 days from baseline
Secondary	PK characteristics	AUC in multiple dose administration period	14 days from baseline
Secondary	PK characteristics	Cav in multiple dose administration period	14 days from baseline