Dry disease
Conditions
Interventions
Test group:Accept a single or mutiple doses of CF04 ophthalmic solution in different concentrations.
Placebo group:Accept a single or multiple doses of placebo.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to enter this study: 1)The subjects signed the informed consent voluntarily, were able to communicate well with the investigators, and understood and were willing to comply with the requirements of the study; 2)Healthy adult subjects, male and female, between the ages of 18 and 50 years (including upper and lower limits), were determined to be in good health by medical history, physical examination, vital signs, 12-lead electrocardiogram, and laboratory examination; 3)Body weight = 45.0 kg for females and =50.0 kg for males, and body mass index (BMI) between 18.0 and 28.0 kg/m2 (including upper and lower limits); 4)BCVA=20/20 in both eyes; 5))Intraocular pressure is between 10-21 mmHg in both eyes (including upper and lower limits); 6) Female subjects: a) Those with no reproductive potential, including surgical sterilization (documented tubal ligation, hysterectomy, or bilateral salpingectomy), as well as those who had been postmenopausal for more than 12 months at the time of the screening visit; b) If there is fertility potential, it must be non-pregnancy, non-lactation, and consent must be given to using two efficient contraceptive methods (one is an efficient method, and the other must be a barrier method) 14 days before administration, during the study period, and within 6 months after administration; 7)Male subjects and their fertile female partners must agree to adopt two different forms of efficient contraception 14 days before medication, during the study period, and within 6 months after medication, and male subjects are not allowed to donate sperm during this period; Subjects undergoing surgical sterilization (such as vasectomy) must provide proof that their semen is free of sperm.
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria will be excluded: 1)Had a severe adverse reaction or allergy to any drug or chemical substance related to this product, such as Poloxamer, or clinically significant allergy to other drugs or foods as assessed by the investigator; 2)History of central nervous, psychiatric, cardiovascular, urinary, digestive, respiratory, metabolic, hematological, immune, endocrine, or musculoskeletal systems or serious diseases that, according to the judgment of the investigator, may endanger the safety of subjects or affect the study results; 3)History of any ocular surgery (including laser correction and intraocular surgery); 4)Having obvious clinical abnormal findings at Screening and Baseline period by binocular fundus examination and slit-lamp examination; 5)Any eye disease assessed by the investigator as unsuitable for inclusion, including but not limited to dry eye, glaucoma, blepharitis, meibomian adenitis, allergic conjunctivitis, iritis, uveitis, and/or active eye inflammation or infection; 6)Subjects with clinically significant eye symptoms within 1 month prior to screening. 7)Previous use of recombinant protein ophthalmic drugs or use of any type of ophthalmic drugs within 1 month prior to screening; 8)The tear film rupture time (TBUT) for both eyes is less than 10 seconds; 9)The length of Schirmer I test tear wetness paper for both eye is less than 10 mm. 10)Subjects who participated in any clinical trial within 3 months prior to screening; 11)Blood loss of more than 400 ml (including 400 ml) due to donation, surgery or other causes within 90 days prior to administration; 12)History of infectious disease, severe trauma or major surgical operation within 1 month prior to screening; 13)Subjects who have used contact lenses (including contact lenses and cosmetic contacts) within 14 days prior to screening or who need to wear contact lenses during the study; 14)Administration of any prescription or herbal medicines, over-the-counter medicines or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks prior to the first administration; 15)Serologically positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); 16)Abnormal chest X-ray results evaluated by the investigator as clinically significant; 17)Subjects who have a chronic problem with alcohol consumption, specifically those who drink more than 14 units (male) and 7 units (female) per week (1 unit =360 ml beer, or 150 ml wine, or 45 ml liquor) or test positive for blood alcohol within 6 months prior to screening; 18)Smoking an average of more than 5 cigarettes per day or consuming an equivalent amount of nicotine or nicotine replacement within 3 months prior to screening; 19)Subjects who cannot be guaranteed to abstain from alcohol and foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to the administration until the end of the last follow-up visit; 20)Subjects who cannot tolerate venous puncture blood collection or have a history of fainting needles and fainting blood; 21)Pregnant or lactating women; 22)Subjects who did not agree to use effective contraception during the study period and for 6 months after the trial ended; 23)History of drug abuse or positive Drug Abuse Screening Test; 24)Subjects with abnormal renal function, including serum c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AE) and severe adverse events (SAE);Vital signs, physical examination, laboratory examination (including blood routine test, urine routine test, biochemical blood test, coagulation function), and 12-lead electrocardiogram;Objective ocular indications:Slit-lamp examination (including evaluation of eyelids, cornea, and conjunctiva)and external eye examination, IOP, corneal fluorescein staining and BCVA etc.;Immunological examination related indicators: Lymphocyte Subset Analysis:CD3+, CD3+CD4+, CD3+CD8+ and CD20+;Cytokine Analysis:IL-6, TNF-a, IFN-? and IL-2.; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of single administration including but not limited to AUC0-t, AUC0-8, Cmax, Tmax, t1/2 and ?z;PK parameters of multiple administration including but not limited to Ra and AUC0-t,AUC0-t,ss, AUC0-8,ss, Cmin,ss, Tmax,ss, t1/2,ss and ?z,ss;Immunogenicity evaluation indicators:Anti CF04 antibody in serum. If the test result of the anti drug antibody is positive, determine whether to test the neutralizing activity of antibodies based on the clinical safety risk assessment.; | — |
Countries
China
Contacts
Public ContactWei Hu/Liming Tao
The Second Hospital of Anhui Medical University
Outcome results
None listed