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

NCT03967548 | Completed Phase 1

• 1 other identifier: ZK-SFT-201909
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corneal Defect

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

0.004% single-dose

EXPERIMENTAL

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

Interventions

Germinal peptide eye drops DRUG

Germinal peptide eye drops of 0.004%

Also known as: shengfatai-eye drops

0.004% single-dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers aged between 18 and 45, both male and female in each group;
• body mass index between 19 and 26 kg/m2 (including critical value), male weight 50 kg, female weight 45 kg;
• 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;
• subjects will participate in the study voluntarily and sign the informed consent.

You may not qualify if:

• binocular corrected vision \< 1.0, abnormal intraocular pressure, slit lamp and fundus examination with clinical significance;
• those with abnormal physical examination, vital signs, electrocardiogram and laboratory examination before the test with clinical significance;
• patients with eye diseases, including history of inner eye surgery or laser surgery;
• 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;
• 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);
• have a significant history of clinical allergy, especially drug allergy, especially allergic to any component of germinal peptide eye drops;
• smoking more than 5 cigarettes per day on average;
• 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;
• history of drug abuse, or positive urine test of ketamine, morphine, methamphetamine, dimethylene dioxyamphetamine, tetrahydrocannabinic acid;
• have taken any medicine within 2 weeks before screening;
• participated in clinical trials within the first 3 months of screening;
• blood donation or blood loss 400 mL within 3 months before screening;
• have used ophthalmic drugs or eyelash growth solution in the first 2 weeks;
• select the subjects who have worn contact lenses or contact lenses in the first 2 weeks;
• the researchers considered the participants unsuitable.

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Xiuli Zhao

Beijing, BJ10, China

Location

Study Officials

• Xiuli Zhao, PHD

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: April 9, 2021
• Primary Completion: May 16, 2021
• Study Completion: June 15, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-05

Locations

CN (1)