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

September 16, 2021 updated by: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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

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

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

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.
106

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

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: 0.004% 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

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
Area under curve （0-t）
Time Frame: Within 12hours after administration
AUC（0-t）
Within 12hours after administration
Area under curve（0-∞）
Time Frame: Within 12hours after administration
AUC（0-∞）
Within 12hours after administration
Peak concentration
Time Frame: Within 12hours after administration
Cmax
Within 12hours after administration
Peak time
Time Frame: Within 12hours after administration
Tmax
Within 12hours after administration
Half life
Time Frame: Within 12hours after administration
t1/2
Within 12hours after administration
Apparent volume of distribution
Time Frame: Within 12hours after administration
Vd
Within 12hours after administration
Elimination rate constant
Time Frame: Within 12hours after administration
Kel
Within 12hours after administration
Mean residence time
Time Frame: Within 12hours after administration
MRT
Within 12hours after administration
Clearance
Time Frame: Within 12hours after administration
CL or CL/F
Within 12hours 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.
April 9, 2021

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.
May 16, 2021

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.
June 15, 2021

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).
May 27, 2019

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.
May 28, 2019

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.
May 30, 2019

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.
September 17, 2021

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.
September 16, 2021

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, 2021

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-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

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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