Fabry disease
Conditions
Interventions
SAD group:D1 15 mg trial drug or placebo,oral single dose
D8 60 mg trial drug or placebo,oral single dose
MAD-cohort1:D1~D14, 30 mg trial drug or placebo, q.d.
MAD-cohort2:D1~D14, 60 mg trial drug or placebo, q.d.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the trial and fully understand the trial's contents, process, and possible adverse reactions; Volunteer to participate and be able to complete the study as required by the protocol. 2. Healthy adult subjects aged 18 to 55 years, no gender limit. 3. Weight >=50kg for males, >=45kg for females. BMI 19-26 kg/m^2. 4. Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings are normal or abnormal as determined by the investigator to be not clinically significant. 5. Female subjects, male subjects, and their female partners have no reproductive plan, no sperm donation, or egg donation plan, and adopt voluntary and effective contraceptive measures, from 2 weeks before screening to 1 month after the last administration of medication.
Exclusion criteria
Exclusion criteria: 1. Patients who have or are developing diseases with clinical abnormalities that need to be excluded before screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (any history of gastrointestinal diseases affecting drug absorption), blood and lymphatic system, urinary system, endocrine system, and immune system diseases. 2. Evidence of active or suspected cancer or a history of malignancy lasting at least 5 years, excluding: cured non-melanoma skin cancer, localized prostate cancer after radical treatment, or other cancers in situ. 3. There are symptomatic virus or bacterial infections during screening. 4. Patients with a history of cataract prior to screening or diagnosed with cataract by ophthalmic examination during screening. 5. Patients who had surgery 3 months before screening or planned surgery during the study period. 6. A history of rapid, severe allergic reactions or other severe allergic reactions to any drug, food, toxin or other exposed substance. 7. Known allergy or hypersensitivity to AL01211 or excipients contained in pharmaceutical preparations. 8. Patients who are currently receiving or have used potentially cataract-causing drugs in the past 1 month, including corticosteroids administered by any route (limited to intermediate-acting and high-potency topical steroids; Does not include intranasal steroids) long-term treatment regimen (more than once every 2 weeks) or any medication that may cause cataracts (e.g. Phenothiazines, pupil reduction agents, amiodarone, allopurinol and phenytoin). 9. Use of any prescription drug (other than the following hormonal contraceptives: OCP, long-acting hormonal implants, injectable hormonal contraceptives, vaginal ring or IUD), over-the-counter drugs, herbs or supplements, or use of vitamins in the 2 weeks prior to administration. 10. Those who were vaccinated within 1 month prior to administration or planned to be vaccinated during the trial. 11. Patients with a history of drug abuse or dependence within the past five years. 12. Those with a history of drug use in the past 5 years. 13. Those who donated more than 400 mL of blood in the previous 3 months, or more than 200 mL of blood within 4 weeks, or planned to donate blood during the clinical trial were screened. 14. Those enrolled in clinical trials of any drug or medical device in the three months prior to screening, or who plan to participate in clinical trials during the trial period. 15. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the trial. 16. Those who consumed more than 14 units of alcohol per week (1 unit = 17.7mL ethanol, i.e., 1 unit = 357mL beer with 5% alcohol or 43mL liquor with 40% alcohol or 147mL wine with 12% alcohol) in the 3 months prior to screening, or who could not stop consuming any alcoholic products during the test period. 17. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250mL) per day in the 3 months prior to screening, or who could not stop drinking during the trial. 18. Use of any inducer or inhibitor of hepatic metabolic enzymes within 28 days prior to administration until the end of the trial. 19. Patients who have taken food or drink (such as grapefruit) containing enzymes that can induce or inhibit liver metabolism within 7 days prior to administratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GL-1 concentration;maximum concentration;area under the concentration-time curve;vital signs;time to reach maximum concentration;laboratory examination;routine 12-leads electrocardiogram;physical examination;adverse events; | — |
Countries
China
Contacts
Public ContactZhao Hui, Hu Wei
Drug Clinical Trial Research Center, the Second Hospital of Anhui Medical University
Outcome results
None listed