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

January 31, 2020 updated by: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, BJ10
        • Xiuli Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Germinal peptide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ocular symptoms
Time Frame: Within two days after administration
Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.
Within two days after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under curve （0-t）
Time Frame: Within two days after administration
AUC（0-t）
Within two days after administration
Area under curve（0-∞）
Time Frame: Within two days after administration
AUC（0-∞）
Within two days after administration
Peak concentration
Time Frame: Within two days after administration
Cmax
Within two days after administration
Peak time
Time Frame: Within two days after administration
Tmax
Within two days after administration
Half life
Time Frame: Within two days after administration
t1/2
Within two days after administration
Apparent volume of distribution
Time Frame: Within two days after administration
Vd
Within two days after administration
Elimination rate constant
Time Frame: Within two days after administration
Kel
Within two days after administration
Mean residence time
Time Frame: Within two days after administration
MRT
Within two days after administration
Clearance
Time Frame: Within two days after administration
CL or CL/F
Within two days after administration
slit lamp examination
Time Frame: Within two days after administration
Examination of cornea, conjunctiva, sclera, lens and vitreous body.
Within two days after administration
fundus examination
Time Frame: Within two days after administration
Observe the change of fundus.
Within two days after administration
intraocular pressure
Time Frame: Within two days after administration
Observe the change of intraocular pressure.
Within two days after administration
vision
Time Frame: Within two days after administration
Observe the change of vision.
Within two days after administration
12-lead ECG
Time Frame: Within two days after administration
Observe the change of 12-lead ECG.
Within two days after administration
AE
Time Frame: Within two days after administration
Observe the occurrence and record of AE.
Within two days after administration
corneal fluorescein staining
Time Frame: Within two days after administration
Observe the change of corneal fluorescein staining.
Within two days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZK-SFT-201704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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