GA and STGD1
Conditions
Interventions
Experimental group:Oral administration, D1-D7 once daily, 5 mg each time.
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent prior to undertaking any study-related activities and must be able to fully understand the nature and purpose of the trial, including possible risks and adverse effects. 2. Healthy males or females between the ages of 18 and 65, with a single sex ratio of not less than 1/3. 3. Body mass index (BMI) 19.0~28.0 kg/m^2 (including boundary value) at screening, weight >=50 kg for male participants and > weight for female participants =45 kg. 4. Healthy volunteers judged by the investigator based on the medical history and no clinically significant abnormalities before the study, including: a) Physical examination, no abnormalities or abnormalities not clinically significant; b) systolic blood pressure in the range of 90 to 139 mmHg and diastolic blood pressure in the range of 60 to 89 mmHg, or abnormality not clinically significant; c) Pulse in the range of 60 to 100 beats/minute, or abnormally non-clinically significant; d) There is no abnormality in body temperature or abnormality is not clinically significant; e) Electrocardiogram (ECG) without clinically significant abnormalities, including Fredericia-corrected QT interval (QTcF, QTcF = QT/RR1/3) for male participants < 450 ms and female participants <470 ms; f) The blood routine, urine routine, blood biochemistry, and coagulation function are normal or abnormal as judged by the investigator to be clinically significant; 5. Female participants must be of non-childbearing potential, i.e., have undergone surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks and more prior to the screening visit) or be postmenopausal (menopause is defined as 12 months without menses without an alternative medical cause and follicle-stimulating hormone (FSH) consistent with postmenopausal status = 40 mUL/mL or according to local laboratory guidelines), or if of childbearing potential: a) No unprotected sex with a male partner within 14 days prior to screening. b) Must have a negative pregnancy test result at the screening visit. c) Must agree not to donate eggs or attempt to conceive from the date of signing the informed consent form until at least 89 days (30 days 5-fold-half-life) after the last dose of study drug. d) If not in a same-sex relationship, must agree to adequate contraception (defined as the use of a condom by the male partner and the use of a highly effective contraceptive method (see Appendix 3 of the protocol for details)) and must not donate eggs for at least 89 days after the last dose of the trial drug. 6. Male participants must: a) Agree not to donate sperm from the date of signing the informed consent form until at least 149 days after the last dose of study drug. b) If sexually active with a female partner who may become pregnant, must agree to use adequate contraception (defined as the use of condoms and highly effective contraceptive methods from the time of signing the informed consent form until at least 149 days after the last dose of study drug (see Appendix 3 of the protocol for details). c) Sexual activity with a non-childbearing female or same-sex partner must agree to use a condom from the time of signing the informed consent form until at least 149 days after the last dose of study drug. 7. Willing and able to comply with all scheduled visits, dosing schedules, clinical laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to the investigational drug or any of its components or other clinically significant reactions. 2. History of clinically significant medical or psychiatric illness (e.g., cardiovascular, respiratory, hepatic, gastrointestinal, renal, genitourinary, endocrine, neuromuscular, rheumatology, tumor, cutaneous, or other diseases) as judged by the investigator. 3. History of any disease that, as judged by the investigator, may affect the results of the study or pose an additional risk to the participant as a result of the participant's participation in the study. 4. Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection, but excluding local skin fungal infection) as judged by the investigator. 5. History of any major surgery within 30 days prior to the first dose. 6. Those who smoke more than 5 cigarettes per day within 28 days before screening or habitually use nicotine-containing products, or are unwilling to quit smoking within 5 days before the administration of the study drug, or are unwilling to quit smoking during the study. 7. Those who have a history of clinically significant thyroid disease in the past or at present as judged by the investigator, and the thyroid-stimulating hormone (TSH) level is beyond the normal range at screening. 8. Alcoholism or regular drinkers within 6 months prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine), or those who have a positive alcohol breath test result during the screening period, or those who have consumed alcohol within 48 hours prior to the use of the study drug, or those who are unable to abstain from alcohol during the trial. 9. Those who abused drugs or used soft drugs (such as marijuana) in the 6 months before screening or took hard drugs (such as amphetamines, phencyclidine and piperidine) in the 1 year before screening; or those who have a positive urine drug test during the screening period. 10. Those with hepatitis B virus infection during the screening period; or positive hepatitis C virus (HCV) antibodies; or positive for human immunodeficiency virus (HIV) antibodies; or positive Treponema pallidum antibodies. 11. The hemoglobin level was lower than the lower limit of normal at screening and was clinically significant. 12. Those who have used the following prescription drugs, over-the-counter drugs, Chinese herbal medicines or supplements during the specified period and cannot avoid or plan to use them during the trial period: a) Any medication (including oral, injectable and ophthalmic drugs) containing systemic prescription vitamin A or vitamin A derivatives. Discontinued at least 30 days prior to screening or during the washout period of the drug, whichever is longer. Other topical medications containing vitamin A or vitamin A derivatives are permitted. b) Any over-the-counter supplement containing vitamin A or vitamin A derivatives. Discontinued at least 30 days prior to screening or during the washout period of the drug, whichever is longer. c) Any known cytochrome P450 enzyme inhibitor/inducer medication or supplement (e.g., clarithromycin, fluvoxamine, ketoconazole, rifampicin, carbamazepine, St. John's wort). Discontinuation of use within at least 30 days prior to the first study dose; or regular consumption of foods that affect cytochrome P450 enzyme activity (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactLu Laichun
Beijing Tongren Hospita
Outcome results
None listed