Neurotrophic keratitis
Conditions
Interventions
A1:HT006.2.2 eye drops/placebo single administration,the dose is 0.195 or 0 µg/ eye/day
A2:HT006.2.2 eye drops/placebo single administration,the dose is 0.780 or 0 µg/ eye/day
A3:HT006.2.2 eye drops/placebo single administration,the dose is 2.340 or 0 µg/ eye/day
A4:HT006.2.2 eye drops/placebo single administration,the dose is 4.680 or 0 µg/ eye/day
B1:HT006.2.2 eye drops/placebo multiple administration,the dose is 0.585 or 0 µg/ eye/day
B2:HT006.2.2 eye drops/placebo multiple administration,the dose is 2.340 or 0 µg/ eye/day
B3:HT006.2.2 eye drops/placebo multiple administration,the dose is 7.020 or 0 µg/ eye/day
B4:HT006.2.2 eye drops/placebo multiple administration,the dose is 14.040 or 0 µg/ eye/day
C-I:HT006.2.2 eye drops single administration,the dose is 20 µg/ml
C-II:HT006.2.2 eye drops single administration,the dose is 20 µg/ml
C-III:HT006.2.2 eye drops single administration,the dose is 60 µg/ml
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. 18-55 years old (including the critical value), male or female; 2. Body mass index (BMI) [weight (kg)/height 2(m2)] is 18.0~26.0 kg/m2 (including the critical value), male weight should be >=50.0 kg, female weight should be >= 45.0kg; 3. Do not have a birth plan for 3 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial; 4. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of drug or food allergy, especially allergic to any ingredient in this product and auxiliary materials; 2. Vital signs, physical examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, immunity eight items, pregnancy test (only for women)) and other examinations during the screening period and baseline period are judged abnormal by the investigators and have clinical significance; 3. Had or has currently suffering from infection, trauma and other eye diseases within 1 month before enrollment, or other eye examinations within 1 month before enrollment are judged abnormal and clinically significant by investigators; 4. Standard logarithmic vision test corrects vision =1 by corneal fluorescein sodium staining during screening; 7. The tear film rupture time of both eyes during screening was =5 cigarettes); 14. Those with a history of alcohol abuse in the 3 months prior to screening (average weekly consumption of >=14 units of alcohol: 1 unit = 285 mL for beer, 25 mL for spirits, or 150 mL for wine) or positive for alcohol breath test prior to enrollment; 15. Previous history of cardiovascular, liver, kidney, lung, digestive tract, nerve and other serious diseases; 16. People who have taken any medicine (prescription, over-the-counter, Chinese herbal medicine) and health products within 14 days before screening; 17. Patients who cannot tolerate venous puncture blood collection and/or have a history of fainting blood and fainting needles; 18. Excessive consumption of tea, coffee and/or beverages rich in caffeine, xanthine and alcohol (more than 8 cups, 1 cup = 250 mL) per day in the 3 months prior to screening; Those who cannot stop consuming caffeinated, alcoholic and other beverages and foods (including chocolate, tea, coffee, cola, etc.), or grapefruit, grapefruit products, dragon fruit, mango, grapefruit, orange, star fruit, guava and other foods from 48 hours before screening to discharge; 19. Persons with a history of drug abuse (including non-medical use of narcotic drugs and psychotropic substances) or positive drug screening (including: morp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, Part B: The occurrence of AE;Part A, Part B: Maximum Tolerated Dose (MTD);Part C: Local pharmacokinetic characteristics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A and Part B: Pharmacokinetic characteristics;Part A, Part B: Immunogenic characteristics;Ocular symptoms, ocular signs and ocular examination;Part C: The occurrence of AE; | — |
Countries
China
Contacts
Public ContactLu Laichun/Jie Ying
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed