None
Conditions
Interventions
Cohort 1:Single dose: once a day, 1 drop per dose 0.04%RM301B or placebo
Multiple dose: 3 times a day, 1 drop per dose 0.04%RM301B or placebo
Cohort 2:Multiple-dose administration only: 6 times daily, 1 drop per dose of 0.04% RM301B or placebo
Cohort 3:Multiple-dose administration only: 8 times daily, 1 drop per dose of 0.04% RM301B or placebo
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult males or females of Chinese nationality aged 18 to 45 years inclusive at the time of signing the informed consent form; 2. During screening, male participants must weigh >=50 kg and female participants >=45 kg, with a BMI between 18 and 26 kg/m² (including the boundary values); 3. Good health status, with normal results for physical examination, vital signs, electrocardiogram (ECG), laboratory tests (complete blood count, blood biochemistry, urinalysis, and serological tests, etc.), trial-related examinations, and ophthalmic examination (slit-lamp examination, intraocular pressure measurement, OCT, and fundus photography, etc.); or results exceeding normal ranges but assessed by the investigator as having no clinical significance; 4. Have fully understood this research, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with a history of drug allergy, especially those who have a history of hypersensitivity, allergic reactions or intolerance to the components of the studied drug (including excipients) and the related examination and operation involved in the study (such as intolerance to venipuncture or a history of fainting at the sight of needles and blood); 2. The best corrected visual acuity (BCVA) of both eyes was measured to be less than 0.8 (0.1 LogMAR) using a standard logarithmic visual acuity chart (decimal recording method); 3. After previous use of steroid drugs (including but not limited to various administration routes such as topical application, injection, oral administration and systemic administration), ocular (significantly elevated intraocular pressure, steroid-induced glaucoma/cataract and aggravated ocular infection, etc.) and systemic (adrenal cortical hyperfunction syndrome, neuropsychiatric concurrent symptoms) have occurred. Subjects with cardiovascular system complications and adverse reactions related to medication such as induced/aggravated ulcers and infections; 4. There is a history of disease that the researcher has determined to be of clinical significance or may affect the safety of the subjects participating in the trial or the in vivo process of the trial drug, including: Those with a clear history of ophthalmic diseases (including periocular diseases), digestive system, blood system, circulatory system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders and metabolic disorders, or other diseases that are not suitable for participating in clinical trials; 5. Subjects with a history of systemic diseases such as diabetes, hypertension and hyperuricemia, or whose screening test results suggest the possibility of systemic diseases; 6. Those who test positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody/antigen, and syphilis serological reaction during screening; 7. During the screening process, any clinically significant abnormalities in ophthalmic specialized examinations that require treatment and/or are considered by the researchers to potentially interfere with the research results were identified, including but not limited to intraocular pressure tests, slit lamp examinations, fundus photography, and OCT. In the past or during screening, one eye had an eye disease, such as high myopia (spherical equivalent exceeding -6.0 diopters), high astigmatism (astigmatism > 4.0 diopters), and other severe refractive errors. Subjects with either eye suffering from dominant strabismus, cataract or other lens damage diseases, glaucoma, shallow anterior chamber, macular degeneration, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, etc. Patients with a previous history of ocular trauma (including orbital trauma), a history of ocular infection (including periocular tissue infection) within 3 months prior to screening, or those who have undergone any ocular surgery; 8. Those who have lost blood or donated blood exceeding 400 mL within the three months prior to screening, or those who plan to donate blood during the trial or within one month after the trial ends; 9. Those who smoked an average of more than 5 cigarettes per day within the 3 months prior to screening and were unable to discontinue the use of any tobacco products at least 48 hours before administration or during the tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP;Fundus examination;Clinical Laboratory Evaluation (Complete Blood Count, Blood Biochemistry, Urinalysis, Coagulation Function Testing);OCT;Vital signs;Urine drug screening;Computerised refraction;Slit lamp examination;Twelve-lead electrocardiogram;BCVA;Coagulation function tests;Fundus photography (FP);Serological testing;RCmax;t1/2;MRT;DF;RAUC0-t;CSS_max;Vd;AUCss;Cav,ss;CSS_min;Cmax;CSS_av;CL;Cav,ss;KEL;AUC0-t;Tmax;AUC?-8; | — |
Countries
China
Contacts
Public ContactZzhishu Bao
Eye Hospital, Wenzhou Medical University
Outcome results
None listed