Corneal DefectPhase 1NCT03662971
Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
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
Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers. 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
- 42 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2018to 24 Oct 2019
- 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;
- The body mass index was between 19 and 26kg/m2 (including the critical value), the weight of male ≥50kg, and that of female ≥45kg；
- 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；
- Before the test, physical examination, vital signs, ECG, laboratory examination were in the normal range or no clinical significance；
- 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;
- Subjects volunteered to participate in the study and signed ICF.
Who cannot join
- Patients with eye diseases, including a history of internal eye surgery or laser surgery;
- History of central nervous system, spirit system, cardiovascular system, kidney system, liver system, respiration system, metabolism and skeletal muscle system;
- 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;
- A significant clinical history of allergic reactions, especially drug allergies, especially allergic to any ingredient in Germinal peptide eye drops;
- Smoking more than 5 cigarettes a day on average;
- 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;
Show all 14Show fewer
- History of drug abuse, or a positive urine test of ketamine, morphine, methamphetamine, dimethylamine and tetrahydrocannabinoid;
- Take any medicine within 2 weeks before screening;
- Participated in clinical trials within 3 months before screening;
- Donation or loss of more than 400 ml of blood within 3 months before screening
- Used ophthalmic drugs or eyelash growth fluid within 2 weeks before screening;
- Used contact lenses or cosmetic contact lenses within 2 weeks before screening;
- Pregnant or lactating women and planned pregnancies (including male subjects);
- The researcher considers that it is not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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 Germinal peptide
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
| Study group | Role | What they receive |
|---|---|---|
| 0.0005% single-dose | Experimental | Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose. Receives: Drug: Germinal peptide eye drops |
| 0.001% single-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.002% single-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.004% single-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.008% single-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.002% multiple-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.004% multiple-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
| 0.008% multiple-dose | Experimental | Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo). Receives: Drug: Germinal peptide eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular symptoms
Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.
Measured: Within two days after administration
Secondary outcomes (16)
Area under curve （0-t）
AUC（0-t）
Measured: Within two days after administration
Area under curve（0-∞）
AUC（0-∞）
Measured: Within two days after administration
Peak concentration
Cmax
Measured: Within two days after administration
Peak time
Tmax
Measured: Within two days after administration
Half life
t1/2
Measured: Within two days after administration
Apparent volume of distribution
Vd
Measured: Within two days after administration
Elimination rate constant
Kel
Measured: Within two days after administration
Mean residence time
MRT
Measured: Within two days after administration
Clearance
CL or CL/F
Measured: Within two days after administration
slit lamp examination
Examination of cornea, conjunctiva, sclera, lens and vitreous body.
Measured: Within two days after administration
fundus examination
Observe the change of fundus.
Measured: Within two days after administration
intraocular pressure
Observe the change of intraocular pressure.
Measured: Within two days after administration
vision
Observe the change of vision.
Measured: Within two days after administration
12-lead ECG
Observe the change of 12-lead ECG.
Measured: Within two days after administration
AE
Observe the occurrence and record of AE.
Measured: Within two days after administration
corneal fluorescein staining
Observe the change of corneal fluorescein staining.
Measured: Within two days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start29 Oct 2018
- Primary completion4 Dec 2018
- Study completion24 Oct 2019
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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 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
- NCT03662971
- Sponsor's protocol ID
- ZK-SFT-201704
- Status last verified
- May 2019
- First submitted
- 28 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03662971
- Acronym / sponsor ID
- ZK-SFT-201704
- Conditions
- Corneal Defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 10 Sep 2018 (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.
Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 0.0005% single-dose | Experimental | Drug: Germinal peptide eye dropsTwo subjects will be treated with Germinal peptide eye drops 0.0005% single dose. |
| 0.001% single-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo). |
| 0.002% single-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo). |
| 0.004% single-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo). |
| 0.008% single-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo). |
| 0.002% multiple-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo). |
| 0.004% multiple-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo). |
| 0.008% multiple-dose | Experimental | Drug: Germinal peptide eye dropsTen subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers aged between 18 and 45, both male and female;
- The body mass index was between 19 and 26kg/m2 (including the critical value), the weight of male ≥50kg, and that of female ≥45kg；
- 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；
- Before the test, physical examination, vital signs, ECG, laboratory examination were in the normal range or no clinical significance；
- 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;
Key exclusion criteria (14 listed)
- Patients with eye diseases, including a history of internal eye surgery or laser surgery;
- History of central nervous system, spirit system, cardiovascular system, kidney system, liver system, respiration system, metabolism and skeletal muscle system;
- 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;
- A significant clinical history of allergic reactions, especially drug allergies, especially allergic to any ingredient in Germinal peptide eye drops;
- Smoking more than 5 cigarettes a day on average;
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: Germinal peptideGerminal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008% | Drug | 0.0005% single-dose, 0.001% single-dose, 0.002% multiple-dose, 0.002% single-dose, 0.004% multiple-dose, 0.004% single-dose, 0.008% multiple-dose, 0.008% single-dose |
Primary outcome
ocular symptoms
Time frame: Within two days after administration
Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.
16 secondary outcomes
Area under curve （0-t）
Time frame: Within two days after administration
Area under curve（0-∞）
Time frame: Within two days after administration
Peak concentration
Time frame: Within two days after administration
Peak time
Time frame: Within two days after administration
Half life
Time frame: Within two days after administration
Apparent volume of distribution
Time frame: Within two days after administration
Elimination rate constant
Time frame: Within two days after administration
Mean residence time
Time frame: Within two days after administration
Clearance
Time frame: Within two days after administration
slit lamp examination
Time frame: Within two days after administration
fundus examination
Time frame: Within two days after administration
intraocular pressure
Time frame: Within two days after administration
vision
Time frame: Within two days after administration
12-lead ECG
Time frame: Within two days after administration
AE
Time frame: Within two days after administration
corneal fluorescein staining
Time frame: Within two days after administration
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 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Corneal Defect
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
Recruiting
Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects
Persistent Epithelial Defect
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 6 inclusion and 14 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 5 Feb 2020. 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?
ocular symptoms (time frame: Within two days after administration). 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 5 Feb 2020.