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Completed

NCT Number: NCT05219461

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

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–51 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Single dose of rhEGF 10mcg/ml or placebo

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: 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 outcomes

  1. PK characteristics

    Time frame: 14 days from baseline

    Cmax in single dose administration period

  2. PK characteristics

    Time frame: 14 days from baseline

    AUC in single dose administration period

  3. PK characteristics

    Time frame: 14 days from baseline

    Cmax in multiple dose adminitration period

  4. PK characteristics

    Time frame: 14 days from baseline

    AUC in multiple dose administration period

  5. PK characteristics

    Time frame: 14 days from baseline

    Cav in multiple dose administration period

Sponsors and collaborators

Lead sponsor

Daewoong Bio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2022
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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