Amblyopia
Conditions
Interventions
Neu-001 group:Eight dose groups: 0.002 mg, 0.005 mg, 0.01 mg, 0.03 mg, 0.06 mg, 0.12 mg, 0.2 mg, and 0.3 mg. A single subcutaneous injection will be administered, and observation will continue until
Placebo group:Eight dose groups, with each group receiving a subcutaneous injection of sterile water for injection in the same volume as the test drug group, and observation continued until 48 hours a
Sponsors
Shanghai First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the trial's purpose, nature, procedures, and potential adverse reactions; volunteer to participate as a subject; and have signed the informed consent form. 2. Aged between 18 and 45 years (inclusive, based on the date of signing the informed consent form); both sexes are eligible. 3. Body Mass Index (BMI) between 19.0 and 30.0 kg/m^2(inclusive) at screening; male weight = 50 kg, female weight = 45 kg. 4. The investigator judges the subject to be in good general health based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory test results (hematology, urinalysis, blood biochemistry, coagulation function), with findings being normal or showing clinically non-significant abnormalities. 5. Female subjects must be non-pregnant, non-lactating, and have a negative pregnancy test result at screening. 6. From screening until 3 months after the last dose, female and male subjects must voluntarily use reliable, highly effective contraceptive methods. Both male and female subjects must not donate sperm or ova during the study and for 3 months after the last dose. 7. Results of intraocular pressure examination, slit-lamp examination, and fundoscopy are normal or show clinically non-significant abnormalities. 8. Best Corrected Visual Acuity (BCVA) of 1.0 in both eyes.
Exclusion criteria
Exclusion criteria: Subjects with any of the following exclusion criteria shall not be enrolled in this trial: 1. Those who have a history of specific allergies (such as urticaria) or have allergies (such as known allergies to two or more substances), or may be allergic to the investigational drug or any component of the investigational drug as judged by the investigator; 2. Those who have a history of chronic diseases or serious diseases in the past, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other conditions that the investigator deems unsuitable for participating in this study; 3. Those who have a history of chronic gastrointestinal tract related diseases such as abdominal pain, bloating, and diarrhea within one year before screening; 4. Those who suffer from infection, trauma and other eye diseases (such as allergic conjunctivitis, herpetic keratitis, iritis, uveitis, etc.) in any eye within 1 month before administration; 5. Those who have symptoms such as anxiety, depression, obsessive-compulsive disorder, panic disorder, fear of heights, or a history of mental illness; 6. Those who have used contact lenses in any eye within 2 weeks before screening, or cannot stop using contact lenses during this study; 7. Those who have a history of drug abuse within 5 years before screening or drug use in 3 months before screening, or have a positive drug abuse screen during the screening period; 8. Those who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months before screening; 9. Those who have drunk an average of more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 40%) or have taken alcohol-containing products in the 48 hours before receiving the test drug, or have a positive alcohol breath test at baseline; 10. Those who have suffered from clinically significant major diseases or undergone major surgical procedures within 6 months before receiving the investigational drug, or who are expected to need major surgery during the trial; 11. From 28 days before receiving the investigational drug to the end of the trial, the subject shall not use any drugs that induce or inhibit liver metabolic enzymes; 12. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before receiving the investigational drug; 13. Those who have used any topical drugs such as eyes and skin within 14 days before receiving the investigational drug; 14. Those who have eaten any food or drink containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, etc.) within 7 days before receiving the investigational drug 15. Those who have eaten any food or beverage containing or metabolized caffeine or xanthines (such as coffee, tea, cola, chocolate) within 48 hours before receiving the test drug; 16. Subjects with positive human immunodeficiency virus antibody (HIV Ab), positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody HCV Ab), or Treponema pallidum antibody (TP Ab) positive during the screening period; 17. Those who have a history of needle sickness and hemosickness, and those who have difficulty or cannot tolerate venipuncture blood collection; 18. Those who have participated in other drug clinical tri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs (blood pressure, pulse, temperature, breathing);Physical examination;12-lead ECGs;Clinical laboratory tests (hematology, urinalysis, blood chemistry and coagulation test);Ophthalmologic examinations;Injection site observation;Adverse events (AEs) / Serious adverse events (SAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactDing Xueying
Shanghai First People's Hospital
Outcome results
None listed