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

NCT ID: NCT03662971

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2019-10-24

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.

Conditions

Corneal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.0005% single-dose

Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose.

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.001% single-dose

Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.002% single-dose

Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.004% single-dose

Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.008% single-dose

Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.002% multiple-dose

Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.004% multiple-dose

Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

0.008% multiple-dose

Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo).

Group Type: EXPERIMENTAL

Germinal peptide eye drops

Intervention Type: DRUG

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

Interventions

Germinal peptide eye drops

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

Intervention Type: DRUG

Other Intervention Names

Germinal peptide

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiuli Zhao, PhD

Role: STUDY_DIRECTOR

Beijing Tongren Hospital

Locations

Xiuli Zhao

Beijing, , China

Countries

China

Other Identifiers

ZK-SFT-201704

Identifier Type: -

Identifier Source: org_study_id