dry eye disease
Conditions
Interventions
Group1:CF04 eye drops 10µg/ml/placebo
Group2:CF04 eye drops 30µg/ml/placebo
Group3:CF04 eye drops 60µg/ml/placebo
Group4:CF04 eye drops 120µg/ml/placebo
Group5:CF04 eye drops 10µg/ml Multiple Doses/placebo
Group6:CF04 eye drops 30µg/ml Multiple Doses/placebo
Group7:CF04 eye drops 60µg/ml Multiple Doses/placebo
Group8:CF04 eye drops 120µg/ml Multiple Doses/placebo
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily signed an informed consent form, were able to communicate well with the investigator, and understood and were willing to comply with the requirements of this study; 2) Healthy adult subjects, male or female, between 18 and 50 years of age (including both ends of the threshold), in good health as determined by past medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory tests; 3) Female subjects weighing = 45 kg and male subjects weighing = 50 kg, with a body mass index (BMI) between 18.0 and 28.0 kg/m2 (including both ends of the threshold); 4) BCVA = 20/20 in both eyes; 5) Intraocular pressure (IOP) between 10-21 mmHg in both eyes (both end thresholds included); 6)Selection of study eye: At screening, both eyes were subjected to ophthalmologic examination as specified in the entry criteria; if both eyes were qualified, the right eye was selected as the study eye; if one eye was qualified, the qualified eye was selected as the study eye; 7) Female subjects: a) of no childbearing potential, including surgically sterilized subjects (documented tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), and subjects who have been post-menopausal with continuous amenorrhea for more than 12 months at the Screening Visit; and b) if of childbearing potential, must be non-pregnant, non-lactating, and must agree to use 2 highly effective methods of contraception (one of which is not available) for 14 days prior to dosing, for the duration of the study, and for 6 months post-dosing. Use of 2 highly effective methods of contraception (1 of which is a highly effective method and 1 of which must be a barrier method); 8) Male subjects and their female partners of childbearing potential must agree to use 2 different forms of highly effective contraception 14 days prior to dosing, during the study period, and for 6 months after dosing, and male subjects must not donate sperm during this period; surgically sterilized subjects (e.g., vasectomized, etc.) must provide proof of sperm absence from semen.
Exclusion criteria
Exclusion criteria: 1)Subjects who have had a serious adverse reaction or allergy to any drug or chemical related to the product such as poloxamer, or who have clinically significant allergies to other drugs or foods as assessed by the investigator; 2)Subjects with a history of central nervous, psychiatric, cardiovascular, urinary, digestive, respiratory, metabolic, hematologic, immunologic, endocrine, or skeletal-muscular system disease or serious illnesses that, in the judgment of the investigator, may jeopardize the subject's safety or affect the results of the study; 3) History of any eye surgery (including laser correction and intraocular surgery, etc.); 4) having clinically significant abnormalities on fundus examination and slit lamp examination in both eyes during the screening and baseline periods; 5) Any ocular disease that is assessed by the investigator to be inappropriate for enrollment, including but not limited to dry eye, glaucoma, blepharitis, blepharitis, allergic conjunctivitis, iritis, uveitis, and/or active ocular inflammation or infection; 6) Those who have developed clinically significant ocular symptoms within 1 month prior to screening; 7) Previous use of recombinant protein-based ophthalmic medications or use of any type of ophthalmic medication within 1 month prior to screening; 8) Those with a tear film break-up time (TBUT) of less than 10 seconds in the study eye; 9) Those with a Schirmer I test tear wetting test strip length of less than 10 mm in the study eye; 10)Those who have participated in any clinical trial within 3 months prior to screening; 11)Those who have lost more than 400 ml (including 400 ml) of blood due to donation, surgery or other reasons within 90 days prior to dosing; 12)Those who have had an infectious disease, severe trauma or history of major surgical operation within 1 month prior to screening; 13)Those who have used corneal contact lenses (including contact lenses and pupils) within 14 days prior to screening or those who need to wear corneal contact lenses during the test; 14)Use of any prescription or herbal medications, over-the-counter medications or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks prior to the first dose; 15)Positive serologic results for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or human immunodeficiency virus antibody (HIV-Ab), or syphilis spirochete antibody (TP-Ab); 16)Those with abnormal results on chest frontal and lateral radiographs that are assessed by the investigator to be clinically significant; 17)Those with a chronic bad drinking habit, specifically: those who have consumed an average of more than 14 units (males) and 7 units (females) of alcohol per week (1 unit = 360 ml of beer, or 150 ml of wine, or 45 ml of liquor) in the 6 months prior to screening, or who have had a positive blood alcohol test; 18)Smoking more than an average of 5 cigarettes per day or ingesting an equivalent amount of nicotine or nicotine replacement in the 3 months prior to screening; 19)Those who cannot guarantee abstinence from smoking, alcohol and xanthine or caffeine-containing foods and beverages (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to drug administration to the end of the last follow-up visit; 20)Those who cannot tolerate blood collection by venipuncture or have a previous history of needle or blood sickness; 21)women who are pregnant or breastfeeding; 22)those who do not agree to use effective
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome (Adverse events, vital signs, physical examination, routine blood test, urinanalysis, blood biochemistry, Coagulation function, 12-lead ECG ); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome (Plasma concentration);Immunogenicity outcome (ADA/nAb); | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed