Clinical trial NCT03662971: Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
Official title: Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Defect
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.

Detailed description: The subjects enrolled in this study are healthy volunteers, divided into single dose groups and multiple doses groups with dose escalation.The study is designed to assign the subjects to five single-dose groups from low to high (0.0005%, 0.001%, 0.002%, 0.004% and 0.008%), and three multiple-dose groups (0.002%, 0.004% and 0.008%), with both male and female subjects in each group. This clinical trial is a double-blind design.

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers aged between 18 and 45, both male and female;
2. The body mass index was between 19 and 26kg/m2 (including the critical value), the weight of male ≥50kg, and that of female ≥45kg；
3. The BCVA of both eyes should be ≥ 1.0, and the intraocular pressure, slit lamp and fundus examination were all normal or abnormal values without clinical significance；
4. Before the test, physical examination, vital signs, ECG, laboratory examination were in the normal range or no clinical significance；
5. Women of childbearing age have negative blood pregnancy test, the subject should ensure that effective contraceptive measures are taken within 1 month before inclusion, and the subject (including male ) is willing to have no pregnancy plan in the next 6 months and voluntarily take effective contraceptive measures;
6. Subjects volunteered to participate in the study and signed ICF.

Exclusion Criteria:

1. Patients with eye diseases, including a history of internal eye surgery or laser surgery;
2. History of central nervous system, spirit system, cardiovascular system, kidney system, liver system, respiration system, metabolism and skeletal muscle system;
3. Positive results of hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies , syphilis spiral antibody (TP-Ab) or r anti-human immunodeficiency virus (HIV) antibodies;
4. A significant clinical history of allergic reactions, especially drug allergies, especially allergic to any ingredient in Germinal peptide eye drops;
5. Smoking more than 5 cigarettes a day on average;
6. Suspicion or actual alcohol dependence; intake of more than 2 units of alcohol per day on average in 3 months (1 unit =10 mL ethanol,, 1 unit =200mL of beer or 25 mL of spirits with 40% alcohol or 83 mL of wine with 12% alcohol) or alcohol test positive;
7. History of drug abuse, or a positive urine test of ketamine, morphine, methamphetamine, dimethylamine and tetrahydrocannabinoid;
8. Take any medicine within 2 weeks before screening;
9. Participated in clinical trials within 3 months before screening;
10. Donation or loss of more than 400 ml of blood within 3 months before screening
11. Used ophthalmic drugs or eyelash growth fluid within 2 weeks before screening;
12. Used contact lenses or cosmetic contact lenses within 2 weeks before screening;
13. Pregnant or lactating women and planned pregnancies (including male subjects);
14. The researcher considers that it is not suitable for the trial.

Primary outcomes:
measure: ocular symptoms
timeFrame: Within two days after administration
Secondary outcomes:
measure: Area under curve （0-t）
timeFrame: Within two days after administration
measure: Area under curve（0-∞）
timeFrame: Within two days after administration
measure: Peak concentration
timeFrame: Within two days after administration
measure: Peak time
timeFrame: Within two days after administration
measure: Half life
timeFrame: Within two days after administration
measure: Apparent volume of distribution
timeFrame: Within two days after administration
measure: Elimination rate constant
timeFrame: Within two days after administration
measure: Mean residence time
timeFrame: Within two days after administration
measure: Clearance
timeFrame: Within two days after administration
measure: slit lamp examination
timeFrame: Within two days after administration
measure: fundus examination
timeFrame: Within two days after administration
measure: intraocular pressure
timeFrame: Within two days after administration
measure: vision
timeFrame: Within two days after administration
measure: 12-lead ECG
timeFrame: Within two days after administration
measure: AE
timeFrame: Within two days after administration
measure: corneal fluorescein staining
timeFrame: Within two days after administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiuli Zhao
Study officials:
affiliation: Beijing Tongren Hospital
name: Xiuli Zhao, PhD
role: STUDY_DIRECTOR
References: