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

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

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

Study Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 106
• 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: Yes
• Genders Eligible for Study: All

Description

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 Ⅰ 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.004% single-dose; 96 subjects will be treated with Germinal peptide eye drops 0.004% single dose (16 were pre-tested and 64 were formally tested).	Drug: Germinal peptide eye drops; Germinal peptide eye drops of 0.004%; Other Names: shengfatai-eye drops

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2021
• Primary Completion (ACTUAL): May 16, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ZK-SFT-201909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No