Clinical trial NCT05806177: Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects
Official title: Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: South China Center For Innovative Pharmaceuticals
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2023-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design
Primary purpose: TREATMENT

Brief summary: This single-center, randomized, placebo-controlled, double-blind, dose-increasing study was designed to evaluate the safety, tolerability, and pharmacokinetics of multiple successive dosing in healthy Chinese adult subjects.In this study, 20 healthy adult subjects were enrolled in a multi-dose study in the 30mg and 40mg groups.

Detailed description: In this study, subjects were given multiple doses in the corresponding dose group

Eligibility criteria: Inclusion Criteria:

1. Healthy subjects were aged 18-45 years (including boundary values), male and female.
2. Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends).
3. Have fully understood this study, voluntarily participated in it, and signed the Informed Consent.
4. Subjects are able to communicate well with researchers and complete the study according to protocol.
5. The subjects were deemed to be in good health based on physical examination, medical history, vital signs, electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests.
6. Subject (including partner) is willing to have no pregnancy plan for the next 30 days (female subject) or 90 days (male subject) and is willing to use effective contraception.

Exclusion Criteria:

1. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
2. The patient has symptoms or related history of any serious disease, including but not limited to heart, liver, kidney, or other acute or chronic digestive tract or respiratory tract diseases, as well as diseases of the blood, endocrine, neurological, psychiatric and other systems, or any other disease or physiological condition that can interfere with the study results.
3. A history of postural hypotension with frequent episodes.
4. A history of frequent nausea or vomiting due to any cause.
5. Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study.
6. Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center.
7. Previous drug abuse history or positive urine drug screening during screening period.
8. Smokers who smoked more than 5 cigarettes a day in the 3 months before the test.
9. Heavy drinkers or regular drinkers in the 6 months prior to the study screening, who drank more than 14 units of alcohol per week (1 unit of alcohol ≈360 mL beer or 45 mL 40% spirits or 150 mL wine) or had a positive alcohol breath test during the screening period.
10. Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day.
11. Take food or drink rich in xanthine, grapefruit or alcohol, caffeine (e.g., dragon fruit, mango, grapefruit, chocolate, coffee or tea) within 48 hours before administration.
12. Surgical procedures, transfusions of blood or blood components in the month prior to study screening.
13. Blood loss or donation of more than 400 mL in the 2 months prior to screening.
14. Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.
15. Study participants who had received any medication in the 28 days prior to screening.
16. Pregnant or lactating women or women who have had unprotected sex within 14 days

Primary outcomes:
measure: Adverse events
timeFrame: day-7 to day11
measure: Serious adverse events
timeFrame: day-7 to day11
measure: Number of participants with abnormal laboratory test results
timeFrame: Screening period (day-7 to day-2) and day11
measure: Number of participants with abnormal vital signs
timeFrame: Screening period（day-7 to day-1）、days1、4、5、6、8、9
measure: Number of participants with abnormal 12-lead electrocardiogram readings
timeFrame: Screening period（day-7 to day-2）、days1、6、11
measure: Number of participants with abnormal physical examination findings
timeFrame: Screening period（day-7 to day-2）、days11
measure: Concomitant medication
timeFrame: Up to day 11
Secondary outcomes:
measure: Tmax of AD16
timeFrame: Up to day 11
measure: Cmax of AD16
timeFrame: Up to day 11
measure: t1/2z of AD16
timeFrame: Up to day 11
measure: AUC 0-∞ of AD16
timeFrame: Up to day 11
measure: AUC 0-t of AD16
timeFrame: Up to day 11
measure: Vd/F of AD16
timeFrame: Up to day 11
measure: CL/F of AD16
timeFrame: Up to day 11
measure: λz of AD16
timeFrame: Up to day 11
measure: AUC 0-48h of AD16
timeFrame: Up to day 11
measure: AUC_%Extrap of AD16
timeFrame: Up to day 11
measure: Tmax,ss of AD16
timeFrame: Up to day 11
measure: Cmax, ss of AD16
timeFrame: Up to day 11
measure: Cavg,ss of AD16
timeFrame: Up to day 11
measure: t1/2,ss of AD16
timeFrame: Up to day 11
measure: AUC 0-τ,ss of AD16
timeFrame: Up to day 11
measure: AUC 0-48h,ss of AD16
timeFrame: Up to day 11
measure: AUC 0-∞,ss of AD16
timeFrame: Up to day 11
measure: CL/F,ss of AD16
timeFrame: Up to day 11
measure: Rac of AD16
timeFrame: Up to day 11
measure: DF of AD16
timeFrame: Up to day 11
measure: Vd/F,ss of AD16
timeFrame: Up to day 11
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Central South University Xiang Ya Hospital
Study officials:
References: