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To evaluate the safety and tolerability of felbinac trometamol eye drops of single-dose, multiple-dose, dose escalation in healthy subjects, for providing the basis for the dose setting in the later clinical study.
In the single-center, randomized, double-blind, placebo-controlled, single-dose dose escalation study, 48 healthy volunteers will be divided from low dose to high dose into 5 single-dose groups of 0.025%, 0.05%, 0.1%, 0.2% and 0.3%, with both male and female subjects in each group. The study was designed as double-blind, all the single-dose groups containing 10 subjects except the single-dose group of 0.025% containing 8 subjects，and with 2 placebo controls in each group.
Pharmacokinetics blood sampling in different dose groups was designed from low dose to high dose into 4 single-dose groups of 0.05%, 0.1%, 0.2% and 0.3%.
In the single-center, randomized, double-blind, placebo-controlled, multiple-dose dose escalation study, 20 healthy volunteers will be divided into low dose and high dose groups of 0.1% and 0.2%, with both male and female subjects in each group. The study was designed as double-blind, all the dose groups containing 8 subjects and 2 placebo controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Group Ⅰ, give the felbinac trometamol eye drops, 0.025%，1 drop，once. Group Ⅱ, give the felbinac trometamol eye drops, 0.05%，1 drop，once. Group Ⅲ, give the felbinac trometamol eye drops, 0.1%，1 drop，once. Group Ⅳ, give the felbinac trometamol eye drops, 0.2%，1 drop，once. Group Ⅴ, give the felbinac trometamol eye drops, 0.3%，1 drop，once. Multiple Group I, give the felbinac trometamol eye drops, 0.1%，1 drop per time，four times each day, for seven days totally. Multiple Group II, give the felbinac trometamol eye drops, 0.2%，1 drop per time，four times each day, for seven days totally. |
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| Placebo group | Placebo Comparator | Group Ⅰ, give the placebo eye drops, 0.0%，1 drop，once. Group Ⅱ, give the placebo eye drops, 0.0%，1 drop，once. Group Ⅲ, give the placebo eye drops, 0.0%，1 drop，once. Group Ⅳ, give the placebo eye drops, 0.0%，1 drop，once. Group Ⅴ, give the placebo eye drops, 0.0%，1 drop，once. Multiple Group I, give the placebo eye drops, 0.0%, 1 drop per time, four times each day, for seven days totally. Multiple Group II, give the placebo eye drops, 0.0%, 1 drop per time, four times each day, for seven days totally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felbinac trometamol eye drop | Drug | Felbinac trometamol eye drop: 0.025%、0.05%、0.1%、0.2%、0.3%, 1 drop will be instilled as instructed over one day in single-dose study; 0.1%, 0.2%, 1 drop per time, four times each day and for seven days totally in multiple-dose study. |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmic examination results in single-dose study | The change of ocular symptoms and signs: baseline (within 60 minutes before administration) and 1 hours±10 minutes after administration | 0 hours before administration (within 60 minutes before administration), and 1 hour±10 minutes after administration |
| Ophthalmic examination results in multiple-dose study | The change of ocular symptoms and signs: baseline (within 60 minutes before the first dose in each day) and 1 hours±10 minutes after each administration | 0 hours before administration (within 60 minutes before first administration in each day), and 1 hour±10 minutes after each administration |
| Ophthalmic examination results in single-dose study | The change of Fundus examination and slit lamp examination: screening period (from Day-14 to Day-1), 24 hours after administration | screening period (from Day-14 to Day-1) , 24 hours after administration |
| Ophthalmic examination results in multiple-dose study | The change of Fundus examination and slit lamp examination: screening period (from Day-14 to Day-1), 48 hours after the last administration | screening period (from Day-14 to Day-1) , 48 hours after the last administration |
| Ophthalmic examination results in single-dose study | The change of Fluorescence staining on cornea: screening period (from Day-14 to Day-1), 4 hours ±20 minutes after administration | screening period(from Day-14 to Day-1) , 4 hours ± 20minutes after administration |
| Ophthalmic examination results in multiple-dose study |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t in single-dose study | the active metabolite biphenylacetic acid in plasma is determined and the pharmacokinetic parameter is calculated. | 0 hour before administration (within 60 minutes before administration) and"10 minutes"，"20 minutes","30 minutes","45 minutes","1 hour ","1.5 hours","2 hours","3 hours","4 hours","6 hours","8 hours","12 hours"and "24 hours"after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wu, Ph.D. | Contact | 010-58268422 | trdrug@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zhao, Ph.D. | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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The study is designed as single dose escalation in the healthy subjects，the subjects are divided from low dose to high dose into 5 single-dose groups of 0.025%, 0.05%, 0.1%, 0.2% and 0.3%, with both male and female subjects in each group.
The study is designed as multiple dose escalation in the healthy subjects，the subjects are divided into low dose and high dose groups of 0.1% and 0.2% with both male and female subjects in each group.
The study was designed as double-blind, all the single-dose groups containing 10 subjects except the single-dose group of 0.025% containing 8 subjects，and with 2 placebo controls in each group.
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| Placebo eye drop | Drug | Placebo eye drop: 0.0%, 1 drop will be instilled as instructed over one day in single-dose study; 0.0%, 1 drop per time, four times each day and for seven days totally in multiple-dose study. |
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The change of Fluorescence staining on cornea: screening period (from Day-14 to Day-1), 4 hours ±20 minutes after the last administration
| screening period(from Day-14 to Day-1) , 4 hours ± 20minutes after the last administration |
| Intraocular pressure values in single-dose study | The change of Intraocular pressure: Screening period (from Day-14 to Day-1), 24 hours after administration | screening period(from Day-14 to Day-1) , 24 hours after administration |
| Intraocular pressure values in multiple-dose study | The change of Intraocular pressure: Screening period (from Day-14 to Day-1), 48 hours after the last administration | screening period(from Day-14 to Day-1) , 48 hours after the last administration |
| Visual acuity values in single-dose study | The change of visual acuity: Screening period (from Day-14 to Day-1), 24 hours after administration | screening period(from Day-14 to Day-1) , 24 hours after administration |
| Visual acuity values in multiple-dose study | The change of visual acuity: Screening period (from Day-14 to Day-1), 48 hours after the last administration | screening period(from Day-14 to Day-1) , 48 hours after the last administration |
| Adverse events (AEs) in single-dose study | The incidence of adverse reactions | All adverse events are collected from the signing of written informed consent up to 24 hours after drug administration. |
| Adverse events (AEs) in multiple-dose study | The incidence of adverse reactions | All adverse events are collected from the signing of written informed consent up to 72 hours after the last drug administration. |
| Serious adverse events (SAEs) in single-dose study | All serious adverse events that occur during the clinical study | All serious adverse events are collected from the signing of written informed consent up to 24 hours after drug administration. |
| Serious adverse events (SAEs) in multiple-dose study | All serious adverse events that occur during the clinical study | All serious adverse events are collected from the signing of written informed consent up to 72 hours after the last drug administration. |
| AUCss0-t in multiple-dose study | the active metabolite biphenylacetic acid in plasma is determined and the pharmacokinetic parameter is calculated. | 0 hour before the last administration (within 15 minutes) and"10 minutes"，"20 minutes","30 minutes","45 minutes","1 hour ","1.5 hours","2 hours","3 hours","4 hours","6 hours","8 hours","12 hours"and "24 hours"after the last dose (steady state) |
| Cmax in single-dose study | the active metabolite biphenylacetic acid in plasma is determined and the pharmacokinetic parameter is calculated. | 0 hour before administration (within 60 minutes before administration) and"10 minutes"，"20 minutes","30 minutes","45 minutes","1 hour ","1.5 hours","2 hours","3 hours","4 hours","6 hours","8 hours","12 hours"and "24 hours"after administration |
| Cmax in multiple-dose study | the active metabolite biphenylacetic acid in plasma is determined and the pharmacokinetic parameter is calculated. | 0 hour before the last administration (within 15 minutes) and"10 minutes"，"20 minutes","30 minutes","45 minutes","1 hour ","1.5 hours","2 hours","3 hours","4 hours","6 hours","8 hours","12 hours"and "24 hours"after the last dose (steady state) |