A Randomized, Placebo-Controlled, Double-Blind, Phase I Study to Evaluate the Safety and Pharmacokinetics of eye drop AVI-4015 in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005175

Enrollment

Registered

2020-06-26

Start date

2020-07-13

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Investigational Proudct: AVI-4015 Dose: AVI-4015 0.1&#37

, 0.3&#37

Part 1 1) 1 cohort: AVI-4015 0.1&#37

, single dose, eye drop (6 Experimental, 2 Placebo comparator) 2) 2 cohort: AVI-4015 0.3&#37

, single dose, eye drop (6 Experimental, 2 Placebo comparator) Part 2 1) 3 cohort: AVI-4015 0.1&#37

, multi dose(twice daily), eye drop, 7 days (6 Experimental, 2 Placebo comparator) 2) 4 cohort: AVI-4015 0.3&#37

, multi dose(twice daily), eye drop, 7 days (6 Experimental, 2 Placebo comparator)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 to 50 2) BMI (Body mass index): 18.5kg/m2 ~ 30kg/m2 3) If the clinical trial is understandable and voluntarily agreed in writing

Exclusion criteria

Exclusion criteria: 1) Patients with a history of clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood/tumor, cardiovascular system, mental disorders (mood disorder, obsessive-compulsive disorder, etc.), gastrointestinal disorders, or surgery 2) Those who have the following diseases or a history of medical problems by medical examination by interview and opthalmic examination. A. People with a history or symptoms of diseases of the eye, including keratitis, uveitis, retinitis, dry eye syndrome, and strabismus. B. corrected visual acuity less than 20/40 (Han Chun-suk visual acuity chart 0.5) C. Those who have undergone ophthalmic surgery before (however, those who have had laser surgery before 24 weeks from the screening examination date are included) D. People who have experienced side effects after wearing contact lenses, or who have worn contact lenses within the past month, or who are unable to comply with the prohibition of wearing contact lenses during the clinical trial period. E. Those who showed abnormal findings in other ophthalmological examinations 3) A person who has taken any specialized drug or herbal medicine within 2 weeks prior to the first day of the scheduled drug administration, or who has taken any general medicine or health functional food or vitamin preparation within 1 week, or who is expected to take it. (However, if other conditions are appropriate according to the investigator's judgment, they may participate in the clinical trial) 4) Those who have had a significant adverse reaction, such as hypersensitivity to clinical trial drugs. 5) Those who showed systolic blood pressure <90 mmHg or> 150 mmHg or diastolic blood pressure <50 mmHg or> 100 mmHg in the vital signs measured in a sitting position after resting for 3 minutes or more. 6) A person who has a history of drug abuse or who has tested positive for an abuse drug in a urine screening test 7) Those who have participated in phase 1 clinical trials or bioequivalence trials with other healthy persons within 6 months prior to the first day of the scheduled drug administration 8) A person who has undergone blood transfusion or ingredient donation within 1 month or has undergone a whole blood donation within 2 months prior to the first day of the scheduled drug administration 9) Those who drink continuously (over 21 units / week, 1 unit = 10 g of pure alcohol) or cannot stop drinking during the hospital stay 10) Those who continuously smoke (more than 10 cigarettes/ day) or cannot stop smoking during the hospital stay 11) Women who are planning to become pregnant or women and men of childbearing potential who have a positive pregnancy test at the screening visit or who do not agree to use at least one *effective contraceptive method that is medically acceptable. However, women who are menopausal for at least one year or who have been found to be unable to become pregnant by surgery are excluded. *effective contraceptive method: Intrauterine devices (loop, mirena), double block (diaphragm or condom / fedomome + spermicide), parenteral contraceptives should be used effectively. Oral contraceptives and only intermittent abstinence (absolute abstinence is permitted) are not acceptable methods. 12) Others who are inappropriate to participate in clinical trials at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Adverse reactions identified in the results of ophthalmic examinations (eye pressure examination, fundus examination, and slit lamp microscopy);Evaluation of local irritation (foreign body sensation, dry eye, soreness, pain, glare, photophobia, blurred vision, unintended tears, etc.) and ocular hyperemia;Evaluation of Visual Analogue Scale (VAS);Monitoring of adverse events such as subjective/objective symptoms, etc.;Vital signs, physical examination, laboratory tests, electrocardiogram (12-lead ECG)	—

Measure

Time frame

Adverse reactions identified in the results of ophthalmic examinations (eye pressure examination, fundus examination, and slit lamp microscopy);Evaluation of local irritation (foreign body sensation, dry eye, soreness, pain, glare, photophobia, blurred vision, unintended tears, etc.) and ocular hyperemia;Evaluation of Visual Analogue Scale (VAS);Monitoring of adverse events such as subjective/objective symptoms, etc.;Vital signs, physical examination, laboratory tests, electrocardiogram (12-lead ECG)

—

Secondary

Measure	Time frame
Pharmacokinetic evaluation (AUCinf, AUClast, Cmax, Tmax, t1/2, R, etc.)	—

Countries

Korea, Republic of

Contacts

Public ContactAeri Lee

Seoul National University Bundang Hospital

Outcome results