NCT05219461

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

December 29, 2021

Last Update Submit

January 27, 2022

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • PK characteristics

    14 days from baseline

  • PK characteristics

    14 days from baseline

  • PK characteristics

    14 days from baseline

  • PK characteristics

    14 days from baseline

  • PK characteristics

    14 days from baseline

Study Arms (6)

Group A rhEGF 10mcg/mL

EXPERIMENTAL

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

Group B rhEGF 50mcg/mL

EXPERIMENTAL

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

Group C rhEGF 100mcg/mL

EXPERIMENTAL

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

Group D rhEGF 10mcg/mL

EXPERIMENTAL

multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo

Drug: Multiple dose of rhEGF 10mcg/ml or placebo

Group E rhEGF 50mcg/mL

EXPERIMENTAL

multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo

Drug: Multiple dose of rhEGF 50mcg/ml or placebo

Group F rhEGF 100mcg/mL

EXPERIMENTAL

multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo

Drug: Multiple dose of rhEGF 100mcg/ml or placebo

Interventions

Single dose of rhEGF 10mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo

Group A rhEGF 10mcg/mL
Single dose of rhEGF 50mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo

Group B rhEGF 50mcg/mL
Single dose of rhEGF 100mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo

Group C rhEGF 100mcg/mL
Multiple dose of rhEGF 10mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo

Group D rhEGF 10mcg/mL
Multiple dose of rhEGF 50mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo

Group E rhEGF 50mcg/mL
Multiple dose of rhEGF 100mcg/ml or placeboDRUG

6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo

Group F rhEGF 100mcg/mL

Eligibility Criteria

Age20 Years - 51 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2021

First Posted

February 2, 2022

Study Start

March 29, 2019

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations

KR(1)