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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662971
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Brief Summary:
Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Corneal Defect Drug: Germinal peptide eye drops Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
Actual Study Start Date : October 29, 2018
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : October 24, 2019

Arm Intervention/treatment
Experimental: 0.0005% single-dose
Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose.
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.001% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.002% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.004% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.008% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.002% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.004% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide

Experimental: 0.008% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo).
Drug: Germinal peptide eye drops
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other Name: Germinal peptide




Primary Outcome Measures :
  1. ocular symptoms [ Time Frame: Within two days after administration ]
    Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.


Secondary Outcome Measures :
  1. Area under curve (0-t) [ Time Frame: Within two days after administration ]
    AUC(0-t)

  2. Area under curve(0-∞) [ Time Frame: Within two days after administration ]
    AUC(0-∞)

  3. Peak concentration [ Time Frame: Within two days after administration ]
    Cmax

  4. Peak time [ Time Frame: Within two days after administration ]
    Tmax

  5. Half life [ Time Frame: Within two days after administration ]
    t1/2

  6. Apparent volume of distribution [ Time Frame: Within two days after administration ]
    Vd

  7. Elimination rate constant [ Time Frame: Within two days after administration ]
    Kel

  8. Mean residence time [ Time Frame: Within two days after administration ]
    MRT

  9. Clearance [ Time Frame: Within two days after administration ]
    CL or CL/F

  10. slit lamp examination [ Time Frame: Within two days after administration ]
    Examination of cornea, conjunctiva, sclera, lens and vitreous body.

  11. fundus examination [ Time Frame: Within two days after administration ]
    Observe the change of fundus.

  12. intraocular pressure [ Time Frame: Within two days after administration ]
    Observe the change of intraocular pressure.

  13. vision [ Time Frame: Within two days after administration ]
    Observe the change of vision.

  14. 12-lead ECG [ Time Frame: Within two days after administration ]
    Observe the change of 12-lead ECG.

  15. AE [ Time Frame: Within two days after administration ]
    Observe the occurrence and record of AE.

  16. corneal fluorescein staining [ Time Frame: Within two days after administration ]
    Observe the change of corneal fluorescein staining.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662971


Locations
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China
Xiuli Zhao
Beijing, China, BJ10
Sponsors and Collaborators
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Investigators
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Study Director: Xiuli Zhao, PhD Beijing Tongren Hospital
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Responsible Party: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT03662971    
Other Study ID Numbers: ZK-SFT-201704
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ophthalmic Solutions
Pharmaceutical Solutions