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

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

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

Study Overview

• Status: Completed
• Conditions: Corneal Defect
• Intervention / Treatment: Drug: Germinal peptide eye drops

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, BJ10
    • Xiuli Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ZK-SFT-201704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No