Myopia
Conditions
Interventions
0.1% STN1013400 Eye drop group:Accept 0.1% STN1013400 eye drops
0.5% STN1013400 Eye drop group:Accept 0.5% STN1013400 eye drops
3% STN1013400 Eye drop group:Accept 3% STN1013400 eye drops
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Those who are judged by the principal investigator/investigator to be able to understand the content of the trial and have the ability to comply with the trial protocol; 2. Those who are able to sign the informed consent form and record the date; 3. Healthy Chinese adult males and females born in China and residing in China; 4. Age of 18 years (inclusive) ~ 45 years old (inclusive) at the time of signing informed consent; 5. At the time of screening, the weight of males >=50kg, the weight of females >=45kg, and the BMI was between 19 (inclusive) ~ 24 (inclusive); 6. Those who agree to take appropriate contraceptive measures from the beginning of signing the informed consent to the end of the trial.
Exclusion criteria
Exclusion criteria: 1.Subjects who received investigational product in another clinical study within 120 days before obtaining informed consent; 2.Subjects previously treated with atropine ophthalmic solution for myopia(except for mydriatic optometry); 3.Subjects with a history of serious eye disease(organic disease), cardiovascular disease, respiratory disease, hepatobiliary disease, digestive disease, urological disease, renal disease, endocrine disease, immune disease, malignancy, metabolic disease, psychoneurological disease, etc; 4.Subjects with eye disease except for myopia, cardiovascular disease, respiratory disease, hepatobiliary disease, digestive disease, urological disease, renal disease, endocrine disease, immune disease, malignancy, metabolic disease, psychoneurological disease, or other abnormalities, excluding myopia, who may affect clinical study participation or clinical study results. 5.Subjects with a history of other risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of long-QT syndrome); 6.Subjects who are seropositive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody/antigen, and syphilis at screen. 7.Corrected visual acuity less than 1.0 (decimal scale) (both eyes); 8.Cycloplegic objective refrection spherical equivalent greater than -3.0 D; 9.IOP>21mmHg at screening; 10.Subjects with a history (at least one) of intraocular surgery, laser treatment of the eye, or ocular trauma. 11.Subjects who wear or need to wear contact lenses between the time of obtaining informed consent and the end of the clinical study. 12.Subjects with a history of drug allergy or idiosyncrasy. 13.Smokers, alcoholics or drug addicts; 14.Subjects who consume alcohol, smoke, or plan to smoke or to consume alcohol between the time of obtaining informed consent and the end of the clinical study; 15.Subjects who test positive for drugs (nicotine, alcohol, or drugs of dependence) at screening. 16.Subjects who have or are scheduled to exercise excessively between the time of obtaining informed consent and the end of the clinical study. 17.A person who has used or intends to use a drug (including OTC drug) between the time of obtaining the consent and the time of end of the study; 18.Subjects who have or are scheduled to receive non-pharmacological treatment (excluding spectacles) between the time of obtaining informed consent and the end of the clinical study. 19.Subjects who donate or plan to donate blood from 3 months before instillation of the investigational drug to the end of the study. 20.Subjects who have participated in other clinical studies and have received or are scheduled to receive the study drug from 3 months before instillation of the investigational drug until the end of the study. 21.Subjects who have difficulty collecting blood from peripheral veins; 22.Pregnant or breastfeeding women. Women who are scheduled to become pregnant between the time of obtaining informed consent and the end of the clinical study; 23.Women who are menstruating or are likely to menstruate during the study treatment period; 24.Subjects judged by the investigator (or subinvestigator) to be ineligible for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of AFDX0249BS AFDX0250BS enantiomers in plasma samples;Adverse Events and Adverse Reactions;12-lead ECG;Eye examination;Vital signs;Laboratory tests; | — |
Countries
China
Contacts
Public ContactShumin Wang
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed