Corneal DefectPhase 1NCT03967548
The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study
A Phase 1 study testing Germinal peptide eye drops in people with Corneal Defect, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial summary
The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Defect
- What is being tested?
- Germinal peptide eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 15 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- the researchers considered the participants unsuitable.
Trial locations and contacts
1 site in 1 country.
About this 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
The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.
Read the 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.
- Conditions
- Corneal Defect
- Being tested
- Germinal peptide eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Germinal peptide eye dropsDrug
Also called shengfatai-eye drops
Germinal peptide eye drops of 0.004%
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Germinal peptide eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve （0-t）
AUC（0-t）
Measured: Within 12hours after administration
Area under curve（0-∞）
AUC（0-∞）
Measured: Within 12hours after administration
Peak concentration
Cmax
Measured: Within 12hours after administration
Peak time
Tmax
Measured: Within 12hours after administration
Half life
t1/2
Measured: Within 12hours after administration
Apparent volume of distribution
Vd
Measured: Within 12hours after administration
Elimination rate constant
Kel
Measured: Within 12hours after administration
Mean residence time
MRT
Measured: Within 12hours after administration
Clearance
CL or CL/F
Measured: Within 12hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start9 Apr 2021
- Primary completion16 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, PHD, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967548
- Sponsor's protocol ID
- ZK-SFT-201909
- Status last verified
- May 2021
- First submitted
- 27 May 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03967548
- Acronym / sponsor ID
- ZK-SFT-201909
- Conditions
- Corneal Defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.004% single-dose | Experimental | Drug: Germinal peptide eye drops96 subjects will be treated with Germinal peptide eye drops 0.004% single dose (16 were pre-tested and 64 were formally tested). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Germinal peptide eye dropsAlso: shengfatai-eye dropsGerminal peptide eye drops of 0.004% | Drug | 0.004% single-dose |
Primary outcome
Area under curve （0-t）
Time frame: Within 12hours after administration
AUC（0-t）
Area under curve（0-∞）
Time frame: Within 12hours after administration
AUC（0-∞）
Peak concentration
Time frame: Within 12hours after administration
Cmax
Peak time
Time frame: Within 12hours after administration
Tmax
Half life
Time frame: Within 12hours after administration
t1/2
Apparent volume of distribution
Time frame: Within 12hours after administration
Vd
Elimination rate constant
Time frame: Within 12hours after administration
Kel
Mean residence time
Time frame: Within 12hours after administration
MRT
Clearance
Time frame: Within 12hours after administration
CL or CL/F
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zhao, PHD study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Germinal peptide eye drops in people with Corneal Defect, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve （0-t） (time frame: Within 12hours after administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.