Optic nerve injury
Conditions
Interventions
Low dose:Dose adjustment
Medium dose:Dose adjustment
High dose:Dose adjustment
Pre test:Dose adjustment
Low dose Multiple administration:Dose adjustment
High dose Multiple administration:Dose adjustment
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy volunteers, half male and half female; 2) The age of the same group of volunteers should not be more than 10 years old; 3) The body weight should not be less than 50 kg, the body mass index (BMI) should be in the range of 18-28 [BMI = weight (kg) / height 2 (M2)], and the weight of the same group of volunteers should be similar; 4) They were in good health, without heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders; 5) Non allergic constitution, no known history of drug allergy; 6) No drug was taken within 2 weeks before the trial; 7) There was no pregnancy or lactation; 8) Voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1) History of NGF treatment or use of other neurotrophic drugs within 3 months before screening 2) After physical examination, blood pressure, electrocardiogram, respiratory status, liver and kidney function, blood and urine routine were abnormal (clinically significant according to the judgment of clinicians); 3) Patients with the following serious diseases, including but not limited to liver, kidney, endocrine, cardiovascular, nervous, mental, gastrointestinal (such as peptic ulcer disease), lung, tumor, immune, skin, or blood related diseases; 4) In the past year, there was a history of alcohol abuse, smoking, drug abuse or drug abuse; 5) Patients with low immune function; 6) Participated in another drug trial or used this trial drug within three months before selection; 7) Those who had undergone major surgery within 6 months before screening; 8) Those who have donated blood within three months before the trial, or intend to donate blood during the trial or within three months after the end of the trial; 9) Viral hepatitis (including hepatitis B and C), AIDS antibody and Treponema pallidum antibody were positive; 10) Taking any prescription drug, over-the-counter drug, any vitamin product or herbal medicine 14 days before taking the study drug; 11) From the screening stage to the beginning of the study, acute disease or combined medication occurred; 12) Had taken any alcoholic products within 48 hours before taking the study medication; 13) It was intolerable to take blood by venipuncture; 14) Poor compliance, difficult to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of anti drug antibody; | — |
Countries
China
Contacts
Public ContactShen Qi
West China Hospital of Sichuan University
Outcome results
None listed