The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study

Corneal Defect Clinical Trial

Official title:

To Evaluate the Local Pharmacokinetic Characteristics of Single Administration of Germinal Peptide Eye Drops in Healthy Volunteers in a Phase I Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967548
• Other study ID #: ZK-SFT-201909
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2021
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.

Description:

Tear collection was conducted on the single dose D1 (that is, the day of administration). Collection points: 10 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h after administration.Each time 5-50 mg (generally 20 mg), a total of 160-1600 mg of tears will be collected (during the screening period, all subjects will retain the tear samples collected by the Schirmer filter paper, among which, qualified tear samples will be used for blank samples or methodological investigation.After administration, only 1 tear collection site will be collected for each subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 15, 2021
• Est. primary completion date: May 16, 2021
• 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 in each group;

2. body mass index between 19 and 26 kg/m2 (including critical value), male weight 50 kg, female weight 45 kg;

3. target eye Schirmer ? test (Schirmer filter paper bending, clip next eyelid medial 1/3 conjunctival sac within 5 min) tear wet filter paper length or greater 10 mm;

4. subjects will participate in the study voluntarily and sign the informed consent.

Exclusion Criteria:

1. binocular corrected vision < 1.0, abnormal intraocular pressure, slit lamp and fundus examination with clinical significance;

2. those with abnormal physical examination, vital signs, electrocardiogram and laboratory examination before the test with clinical significance;

3. patients with eye diseases, including history of inner eye surgery or laser surgery;

4. a medical history of central nervous system, spirit, cardiovascular system, kidney, liver, respiratory system, metabolism system and skeletal muscle system, which may endanger the safety of subjects or affect the results of the study;

5. positive test results of hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (hcv-ab), treponema pallidum specific antibody (tp-ab) or human immunodeficiency virus antibody (hiv-p24 /Ab);

6. have a significant history of clinical allergy, especially drug allergy, especially allergic to any component of germinal peptide eye drops;

7. smoking more than 5 cigarettes per day on average;

8. those who are suspected or have alcohol dependence, and their alcohol intake is more than 2 units per day on average for 3 months (1 unit =10 mL ethanol, that is, 1 unit =200 mL beer with 5% alcohol or 25 mL spirit with 40% alcohol or 83 mL wine with 12% alcohol) or who have tested positive for alcohol;

9. history of drug abuse, or positive urine test of ketamine, morphine, methamphetamine, dimethylene dioxyamphetamine, tetrahydrocannabinic acid;

10. have taken any medicine within 2 weeks before screening;

11. participated in clinical trials within the first 3 months of screening;

12. blood donation or blood loss 400 mL within 3 months before screening;

13. have used ophthalmic drugs or eyelash growth solution in the first 2 weeks;

14. select the subjects who have worn contact lenses or contact lenses in the first 2 weeks;

15. pregnant or lactating women and those planning to become pregnant (including male subjects);No effective contraceptive measures were taken within 1 month prior to the inclusion of subjects, or subjects (including male subjects) were unwilling to take effective contraceptive measures within the next 6 months;

16. the researchers considered the participants unsuitable.

Related Conditions & MeSH terms

• Corneal Defect

Intervention

Drug:
• Germinal peptide eye drops
Germinal peptide eye drops of 0.004%

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	Area under curve (0-t)	AUC(0-t)	Within 12hours after administration
Primary	Area under curve(0-8)	AUC(0-8)	Within 12hours after administration
Primary	Peak concentration	Cmax	Within 12hours after administration
Primary	Peak time	Tmax	Within 12hours after administration
Primary	Half life	t1/2	Within 12hours after administration
Primary	Apparent volume of distribution	Vd	Within 12hours after administration
Primary	Elimination rate constant	Kel	Within 12hours after administration
Primary	Mean residence time	MRT	Within 12hours after administration
Primary	Clearance	CL or CL/F	Within 12hours after administration