Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: Single dose of rhEGF 50mcg/ml or placeboDrug: Multiple dose of rhEGF 50mcg/ml or placeboDrug: Single dose of rhEGF 100mcg/ml or placeboDrug: Multiple dose of rhEGF 10mcg/ml or placeboDrug: Single dose of rhEGF 10mcg/ml or placeboDrug: Multiple dose of rhEGF 100mcg/ml or placebo
- Registration Number
- NCT05219461
- Lead Sponsor
- Daewoong Bio Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
- 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
- Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B rhEGF 50mcg/mL Single dose of rhEGF 50mcg/ml or placebo single dose of rhEGF 50mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily) Group E rhEGF 50mcg/mL Multiple dose of rhEGF 50mcg/ml or placebo multiple dose of rhEGF 50mcg/mL eye drop or multiple dose of placebo Group C rhEGF 100mcg/mL Single dose of rhEGF 100mcg/ml or placebo single dose of rhEGF 100mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily) Group D rhEGF 10mcg/mL Multiple dose of rhEGF 10mcg/ml or placebo multiple dose of rhEGF 10mcg/mL eye drop or multiple dose of placebo Group A rhEGF 10mcg/mL Single dose of rhEGF 10mcg/ml or placebo single dose of rhEGF 10mcg/mL eye drop or single dose of placebo \*single dose means daily dose (administration twice daily) Group F rhEGF 100mcg/mL Multiple dose of rhEGF 100mcg/ml or placebo multiple dose of rhEGF 100mcg/mL eye drop or multiple dose of placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method PK characteristics 14 days from baseline Cav in multiple dose administration period
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Bundang Hospital🇰🇷Seongnam-si, Korea, Republic of