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

Phase 1

Completed

• Conditions: Corneal Defect
• Interventions: Drug: Germinal peptide eye drops

• Registration Number: NCT03662971
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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.

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-10
• Study Start: 2018-10-29
• Primary Completion: 2018-12-04
• Status Verified: 2019-05
• Study Completion: 2019-10-24
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
0.008% multiple-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo).
0.001% single-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo).
0.002% single-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo).
0.004% single-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo).
0.008% single-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo).
0.002% multiple-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo).
0.004% multiple-dose	Germinal peptide eye drops	Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo).
0.0005% single-dose	Germinal peptide eye drops	Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose.

Primary Outcome Measures

Name	Time	Method
ocular symptoms	Within two days after administration	Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xiuli Zhao; 🇨🇳 Beijing, China