Back to resultsPharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single dose of rhEGF 10mcg/ml or placebo
Single dose of rhEGF 50mcg/ml or placebo
Single dose of rhEGF 100mcg/ml or placebo
Multiple dose of rhEGF 10mcg/ml or placebo
Multiple dose of rhEGF 50mcg/ml or placebo
Multiple dose of rhEGF 100mcg/ml or placebo
Sponsored by
About this trial
This is an interventional screening trial for Dry Eye Syndromes
Eligibility Criteria
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)
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A rhEGF 10mcg/mL
Group B rhEGF 50mcg/mL
Group C rhEGF 100mcg/mL
Group D rhEGF 10mcg/mL
Group E rhEGF 50mcg/mL
Group F rhEGF 100mcg/mL
Arm Description
single dose of rhEGF 10mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)
single dose of rhEGF 50mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)
single dose of rhEGF 100mcg/mL eye drop or single dose of placebo *single dose means daily dose (administration twice daily)
multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
PK characteristics
Cmax in single dose administration period
PK characteristics
AUC in single dose administration period
PK characteristics
Cmax in multiple dose adminitration period
PK characteristics
AUC in multiple dose administration period
PK characteristics
Cav in multiple dose administration period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05219461
Brief Title
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Bio Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A rhEGF 10mcg/mL
Arm Type
Experimental
Arm Description
single dose of rhEGF 10mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
Arm Title
Group B rhEGF 50mcg/mL
Arm Type
Experimental
Arm Description
single dose of rhEGF 50mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
Arm Title
Group C rhEGF 100mcg/mL
Arm Type
Experimental
Arm Description
single dose of rhEGF 100mcg/mL eye drop or single dose of placebo
*single dose means daily dose (administration twice daily)
Arm Title
Group D rhEGF 10mcg/mL
Arm Type
Experimental
Arm Description
multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo
Arm Title
Group E rhEGF 50mcg/mL
Arm Type
Experimental
Arm Description
multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo
Arm Title
Group F rhEGF 100mcg/mL
Arm Type
Experimental
Arm Description
multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
Intervention Type
Drug
Intervention Name(s)
Single dose of rhEGF 10mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
Intervention Type
Drug
Intervention Name(s)
Single dose of rhEGF 50mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
Intervention Type
Drug
Intervention Name(s)
Single dose of rhEGF 100mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Intervention Type
Drug
Intervention Name(s)
Multiple dose of rhEGF 10mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo
Intervention Type
Drug
Intervention Name(s)
Multiple dose of rhEGF 50mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo
Intervention Type
Drug
Intervention Name(s)
Multiple dose of rhEGF 100mcg/ml or placebo
Intervention Description
6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Description
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)
Time Frame
14 days from baseline
Secondary Outcome Measure Information:
Title
PK characteristics
Description
Cmax in single dose administration period
Time Frame
14 days from baseline
Title
PK characteristics
Description
AUC in single dose administration period
Time Frame
14 days from baseline
Title
PK characteristics
Description
Cmax in multiple dose adminitration period
Time Frame
14 days from baseline
Title
PK characteristics
Description
AUC in multiple dose administration period
Time Frame
14 days from baseline
Title
PK characteristics
Description
Cav in multiple dose administration period
Time Frame
14 days from baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
We'll reach out to this number within 24 hrs