Mild to moderate Alzheimer's disease
Conditions
Interventions
Single Dose Administration Study - Dose Group 1.:Single oral administration of BrAD-R13 5 mg or placebo under fasting condition
Single Dose Administration Study - Dose Group 2 .:Single oral administration of BrAD-R13 10mg or placebo under fasting condition
Single Dose Administration Study - Dose Group 3 .:Single oral administration of BrAD-R13 25mg or placebo under fasting condition
Single Dose Administration Study - Dose Group 4 .:Single oral administration of BrAD-R13 50mg or placebo under fasting condition
Single Dose Administration Study - Dose Group 5 .:Single oral administration of BrAD-R13 100mg or placebo under fasting condition
Single Dose Administration Study - Dose Group 6 .:Single oral administration of BrAD-R13 150mg or 200mg or placebo under fasting condition
Food effect group - Sequence 1:Eight healthy subjects were selected and administered according to a fasted-fed dosing regimen.
Food effect group - Sequence 2:The 8 subjects in sequence 1 were administered according to a fed-fasted dosing regimen.
Multiple Dosing Study - Dose Group 1:The dosage was 50mg and the patient s tolerance, safety, and PK data were evaluated 72 hours (10th day) after 7 days of administration.
Multiple Dosing Study - Dose Group 2:Evaluate whether to proceed with the next dose group study based on the tolerance, safety, and PK data of the previous dose group 72 hours after administration on
Multiple Dosing Study - Dose Group 3:Tolerability, safety and PK data at 72h after Day 7 administration of the 100mg dose group will be used to assess whether to conduct a study in this dose group. If
Sponsors
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18 to 45 (including 18 and 45 years old, subject to signing of informed consent form). 2. The weight of male subjects shall not be less than 50.0 kg, and the weight of female subjects shall not be less than 45.0 kg. Body mass index (BMI)=weight (kg)/height 2 (m2), with a body mass index ranging from 18.0 to 26.0 kg/m2 (including critical values). 3. No history of serious diseases such as heart, liver, kidney, nervous system, gastrointestinal tract, mental disorders, and metabolic abnormalities. 4. Vital signs, physical examination, laboratory examination, chest X-ray, abdominal ultrasound, 12 lead electrocardiogram and other indicators are normal or abnormal without clinical significance. 5. During the trial period and within 3 months after the end of the trial, the subjects did not have a fertility plan and voluntarily adopted effective contraceptive measures, and did not have plans to donate sperm or eggs. 6. Before the trial, fully understand the content, process, and potential adverse reactions of the trial, and voluntarily sign an informed consent form. 7. Able to complete the research according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with allergic constitution (such as known allergies to two or more drugs), a history of severe multiple allergies and/or severe allergies (including latex/heparin allergies), or known allergies to any component of this drug (pre gelatinized starch, mannitol, cross-linked carboxymethyl cellulose sodium, hydroxypropylmethylcellulose, magnesium stearate, colloidal silica, film coated premix (gastric soluble)) .(inquiry). 2. Screening for patients with acute diseases within the first 2 weeks (inquiry). 3. Screening for individuals who have received live attenuated vaccines within the first 2 weeks or who need to receive live attenuated vaccines during the trial period (inquiry). 4. Those who meet any of the following criteria: those whose liver function test values (total bilirubin, direct bilirubin, ALT, AST, GGT, and ALP) exceed the upper limit of the central normal value (examination). 5. During screening, the electrocardiogram results showed an extended QTc interval, with QTc>450ms for males and QTc>470ms for females (Fridericia's correction formula for QT interval: QTc=QT/RR0.33) (examination). 6. Patients with a blood creatinine clearance rate of<80mL/min (creatinine clearance rate=(140 -age) × Body weight (kg)/(0.818 × Creatinine value( µ Mol/L), if female, it needs to be multiplied by 0.85) (refer to Cockcroft Fault (C-G) formula) (check). 7. Those who are positive for hepatitis B virus surface antigen or core antibody, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody (examination). 8. Individuals with a history of drug dependence or abuse, or those with positive urine drug abuse screening (inquiry and examination). 9. Smokers (who smoke an average of 5 or more cigarettes per day or habitually use nicotine containing products) within the first 3 months of screening, or those who cannot stop using any tobacco products during the trial period (inquiry). 10. Screening for individuals who have been addicted to alcohol within the previous year (with an average weekly alcohol consumption of 2 or more units, each equivalent to 360 mL of beer, 150 mL of wine, or 45 mL of alcohol containing 40% alcohol), or those who have consumed alcohol within 48 hours before medication, or those who cannot abstain from alcohol during the trial period, or those whose alcohol breath test results are greater than 0.0 mg/100 mL (inquiry, examination). 11. Individuals who have participated in any clinical trial of drugs or medical devices within the first 3 months of screening (inquiry). 12. Screening for individuals who have donated blood or lost = 400 mL of blood within the first 3 months, or have previously had unexplained abnormal bleeding (excluding female physiological periods), or have received blood transfusions; Blood donation or loss of = 200 mL (excluding female physiological period) within one month before screening (inquiry). 13. Those who have infectious diseases (judged by the investigator to affect the ability of the subject to participate in the test), serious trauma or have a history of major surgery within 3 months, or who have undergone surgery that judged by the investigator to affect the absorption, distribution, metabolism and excretion of drugs, or who plan to perform surgery during the study period (inquiry). 14. Inability to tolerate venous puncture/indwelling needle blood collection or a history of needle or blood fainting (inquiry). 15. It is not guaranteed to stop
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Laboratory test indicators;The incidence and severity of treatment-emergent adverse event (TEAE) and serious adverse event (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK); | — |
Countries
China
Contacts
Public ContactZhai Xuejia
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed