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

• Sponsor: Daewoong Bio Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05219461
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 6
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 6.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	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	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• 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
• Actual Study Start Date: Mar 29, 2019
• Actual Primary Completion Date: Nov 13, 2019
• Actual Study Completion Date: Nov 13, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. PK characteristics [14 days from baseline]

   Cmax in single dose administration period

2. PK characteristics [14 days from baseline]

   AUC in single dose administration period

3. PK characteristics [14 days from baseline]

   Cmax in multiple dose adminitration period

4. PK characteristics [14 days from baseline]

   AUC in multiple dose administration period

5. PK characteristics [14 days from baseline]

   Cav in multiple dose administration period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 51 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of

Sponsors and Collaborators

• Daewoong Bio Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Bio Inc.
• ClinicalTrials.gov Identifier: NCT05219461
• Other Study ID Numbers: DW_EGF102OP
• First Posted: Feb 2, 2022
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Feb 2, 2022