Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers

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

Detailed Description
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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.

Official Title
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Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers

Conditions
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Corneal Defect

Intervention / Treatment
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* Drug: Germinal peptide eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between 18 and 45, both male and female; The body mass index was between 19 and 26kg/m2 (including the critical value), the weight of male ≥50kg, and that of female ≥45kg； 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； Before the test, physical examination, vital signs, ECG, laboratory examination were in the normal range or no clinical significance； 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; Subjects volunteered to participate in the study and signed ICF. Exclusion Criteria: Patients with eye diseases, including a history of internal eye surgery or laser surgery; History of central nervous system, spirit system, cardiovascular system, kidney system, liver system, respiration system, metabolism and skeletal muscle system; 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; A significant clinical history of allergic reactions, especially drug allergies, especially allergic to any ingredient in Germinal peptide eye drops; Smoking more than 5 cigarettes a day on average; 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; History of drug abuse, or a positive urine test of ketamine, morphine, methamphetamine, dimethylamine and tetrahydrocannabinoid; Take any medicine within 2 weeks before screening; Participated in clinical trials within 3 months before screening; Donation or loss of more than 400 ml of blood within 3 months before screening Used ophthalmic drugs or eyelash growth fluid within 2 weeks before screening; Used contact lenses or cosmetic contact lenses within 2 weeks before screening; Pregnant or lactating women and planned pregnancies (including male subjects); The researcher considers that it is not suitable for the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.0005% single-dose<br>Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose. | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.001% single-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.002% single-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.004% single-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.008% single-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.002% multiple-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.004% multiple-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|
| Experimental: 0.008% multiple-dose<br>Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo). | Drug: Germinal peptide eye drops<br>* Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%<br>* Other names: Germinal peptide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular symptoms | Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow. | Within two days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve （0-t） | AUC（0-t） | Within two days after administration | 
| Area under curve（0-∞） | AUC（0-∞） | Within two days after administration | 
| Peak concentration | Cmax | Within two days after administration | 
| Peak time | Tmax | Within two days after administration | 
| Half life | t1/2 | Within two days after administration | 
| Apparent volume of distribution | Vd | Within two days after administration | 
| Elimination rate constant | Kel | Within two days after administration | 
| Mean residence time | MRT | Within two days after administration | 
| Clearance | CL or CL/F | Within two days after administration | 
| slit lamp examination | Examination of cornea, conjunctiva, sclera, lens and vitreous body. | Within two days after administration | 
| fundus examination | Observe the change of fundus. | Within two days after administration | 
| intraocular pressure | Observe the change of intraocular pressure. | Within two days after administration | 
| vision | Observe the change of vision. | Within two days after administration | 
| 12-lead ECG | Observe the change of 12-lead ECG. | Within two days after administration | 
| AE | Observe the occurrence and record of AE. | Within two days after administration | 
| corneal fluorescein staining | Observe the change of corneal fluorescein staining. | Within two days after administration |