Clinical trial NCT03967548: The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Defect
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area under curve （0-t）
timeFrame: Within 12hours after administration
measure: Area under curve（0-∞）
timeFrame: Within 12hours after administration
measure: Peak concentration
timeFrame: Within 12hours after administration
measure: Peak time
timeFrame: Within 12hours after administration
measure: Half life
timeFrame: Within 12hours after administration
measure: Apparent volume of distribution
timeFrame: Within 12hours after administration
measure: Elimination rate constant
timeFrame: Within 12hours after administration
measure: Mean residence time
timeFrame: Within 12hours after administration
measure: Clearance
timeFrame: Within 12hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiuli Zhao
Study officials:
affiliation: Beijing Tongren Hospital
name: Xiuli Zhao, PHD
role: STUDY_DIRECTOR
References: