Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic properties of EB-203 eye drops in healthy adult volunteers
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0008881
- Lead Sponsor
- Eyebiokorea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 28
1. Healthy adult males between the ages of 20 and 55 years
2. Body Weight > 55 kg and BMI 18 ~ 27 kg/m2
3. Patients signed informed consent willing and able to sign informed consent form and comply with visit and study procedures per protocol
1. A person who has a history or presence of clinical significant Cardiovascular, Respiratory, Hepatobiliary, Renal/Urinary, Hematological, Gastrointestinal, Endocrine, Neurological, Psychiatric disease
2. A person who has the following diseases from medical and ophthalmic examination
1) Suspected symptoms or signs of visual organ disease including corneitis, uveitis, retinitis, dry eyes, and strabismus
2) Corrected visual acuity < 20/25 or Intraocular Pressure > 21 mmHg
3) Patients who have received any eye surgery
4) Other abnormal findings in ophthalmic examinations
3. Other patients considered by investigators to be inappropriate as subjects.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event and Adverse Drug Reaction collected from History taking, Review of systems, Physical examination, Vital sign, ECG, Clinical laboratory test, Ophthalmological examination
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Variable((AUC, Cmax, Tmax, t1/2 et al)