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

Corneal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662971
• Other study ID #: ZK-SFT-201704
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2018
• Est. completion date: October 24, 2019

Study information

• Verified date: May 2019
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 24, 2019
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Defect

Intervention

Drug:
• Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%

Locations

Country	Name	City	State
China	Xiuli Zhao	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular symptoms	Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.	Within two days after administration
Secondary	Area under curve (0-t)	AUC(0-t)	Within two days after administration
Secondary	Area under curve(0-8)	AUC(0-8)	Within two days after administration
Secondary	Peak concentration	Cmax	Within two days after administration
Secondary	Peak time	Tmax	Within two days after administration
Secondary	Half life	t1/2	Within two days after administration
Secondary	Apparent volume of distribution	Vd	Within two days after administration
Secondary	Elimination rate constant	Kel	Within two days after administration
Secondary	Mean residence time	MRT	Within two days after administration
Secondary	Clearance	CL or CL/F	Within two days after administration
Secondary	slit lamp examination	Examination of cornea, conjunctiva, sclera, lens and vitreous body.	Within two days after administration
Secondary	fundus examination	Observe the change of fundus.	Within two days after administration
Secondary	intraocular pressure	Observe the change of intraocular pressure.	Within two days after administration
Secondary	vision	Observe the change of vision.	Within two days after administration
Secondary	12-lead ECG	Observe the change of 12-lead ECG.	Within two days after administration
Secondary	AE	Observe the occurrence and record of AE.	Within two days after administration
Secondary	corneal fluorescein staining	Observe the change of corneal fluorescein staining.	Within two days after administration