Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- ocular symptoms
研究概览
简要总结
Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
0.0005% single-dose
Two subjects will be treated with Germinal peptide eye drops 0.0005% single dose.
干预措施: Germinal peptide eye drops (Drug)
0.001% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.001% single dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.002% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.002% single dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.004% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.004% single dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.008% single-dose
Ten subjects will be treated with Germinal peptide eye drops 0.008% single dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.002% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.002% multiple dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.004% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.004% multiple dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
0.008% multiple-dose
Ten subjects will be treated with Germinal peptide eye drops 0.008% multiple dose (eight treatment and two placebo).
干预措施: Germinal peptide eye drops (Drug)
结局指标
主要结局
ocular symptoms
时间窗: Within two days after administration
Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.
次要结局
- Elimination rate constant(Within two days after administration)
- Apparent volume of distribution(Within two days after administration)
- fundus examination(Within two days after administration)
- intraocular pressure(Within two days after administration)
- Area under curve （0-t）(Within two days after administration)
- Mean residence time(Within two days after administration)
- slit lamp examination(Within two days after administration)
- 12-lead ECG(Within two days after administration)
- Peak concentration(Within two days after administration)
- Half life(Within two days after administration)
- Area under curve（0-∞）(Within two days after administration)
- Peak time(Within two days after administration)
- Clearance(Within two days after administration)
- vision(Within two days after administration)
- AE(Within two days after administration)
- corneal fluorescein staining(Within two days after administration)