Clinical trial NCT05787028: Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Official title: Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: South China Center For Innovative Pharmaceuticals
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2023-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A single-center, randomized, placebo-controlled, double-blind, dose-increasing study
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults under fasting conditions, and the secondary objective was to preliminarily evaluate the material balance of single administration of AD16 tablets in fasting conditions.

The study is divided into two parts: preliminary test and formal test. The formal trial was a single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5 dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively).

Ten subjects (male and female) were enrolled in each dose group, of which 8 received the experimental drug and 2 received placebo.

Urine and fecal samples were collected in the 20mg dose group for material balance study.Urine and fecal samples were collected in the 20mg dose group for material balance study.


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. Surgical procedures, transfusions of blood or blood components in the month prior to study screening.
12. Blood loss or donation of more than 400 mL in the 2 months prior to screening.
13. Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.
14. Study participants who had received any medication in the 28 days prior to screening.
15. Pregnant or lactating women or women who have had unprotected sex within 14 days.
16. Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.

Primary outcomes:
measure: Adverse events
timeFrame: day-7 to day3
measure: Serious adverse events
timeFrame: day-7 to day3
measure: Number of participants with abnormal laboratory test results
timeFrame: Screening period (day-7 to day-2) and day3
measure: Number of participants with abnormal vital signs
timeFrame: day-7 to day3
measure: Number of participants with abnormal 12-lead electrocardiogram readings
timeFrame: Screening period (day-7 to day-2) and day3
measure: Number of participants with abnormal physical examination findings
timeFrame: Screening period (day-7 to day-2) and day3
measure: Concomitant Medication
timeFrame: up to day3
measure: Tmax of AD16
timeFrame: day1 to day3
measure: Cmax of AD16
timeFrame: day1 to day3
measure: t1/2z of AD16
timeFrame: day1 to day3
measure: AUC 0-∞ of AD16
timeFrame: day1 to day3
measure: AUC 0-t of AD16
timeFrame: day1 to day3
measure: CL/F of AD16
timeFrame: day1 to day3
measure: Vd/F of AD16
timeFrame: day1 to day3
measure: λz of AD16
timeFrame: day1 to day3
measure: Mean retention time（MRT ）of AD16
timeFrame: day1 to day3
Secondary outcomes:
measure: Ae
timeFrame: day-3 to day3
measure: Fe0-t
timeFrame: day-3 to day3
measure: Renal clearance
timeFrame: day-3 to day3
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Central South University Xiang Ya Hospital
Study officials:
References: