search
Back to results

Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration (AD16)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg
AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy subjects were aged 18-45 years (including boundary values), male and female. Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends). Have fully understood this study, voluntarily participated in it, and signed the Informed Consent. Subjects are able to communicate well with researchers and complete the study according to protocol. 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. 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: Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody. 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. A history of postural hypotension with frequent episodes. A history of frequent nausea or vomiting due to any cause. Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study. Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center. Previous drug abuse history or positive urine drug screening during screening period. Smokers who smoked more than 5 cigarettes a day in the 3 months before the test. 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. Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day. Surgical procedures, transfusions of blood or blood components in the month prior to study screening. Blood loss or donation of more than 400 mL in the 2 months prior to screening. Participated in other clinical studies and took experimental drugs within 3 months prior to study screening. Study participants who had received any medication in the 28 days prior to screening. Pregnant or lactating women or women who have had unprotected sex within 14 days. Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.

Sites / Locations

  • The Central South University Xiang Ya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AD16

placebo

Arm Description

The experimental group received AD16, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day.7 dosing cohorts will receive a single oral dose of AD16.

The placebo group received AD16 placebo, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day. 7 dosing cohorts will receive a single oral dose of AD16 placebo.

Outcomes

Primary Outcome Measures

Adverse events
The number of adverse events
Serious adverse events
The number of serious adverse events
Number of participants with abnormal laboratory test results
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine
Number of participants with abnormal vital signs
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Number of participants with abnormal 12-lead electrocardiogram readings
abnormal 12-lead electrocardiogram readings
Number of participants with abnormal physical examination findings
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Concomitant Medication
Any concomitant medication
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
Cmax of AD16
Maximum (peak) plasma drug concentration
t1/2z of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
AUC 0-∞ of AD16
AUC 0-∞ is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). area under curve(AUC)
AUC 0-t of AD16
AUC 0-t is defined as the concentration of drug from time zero to the last quantifiable concentration.area under curve(AUC)
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). administration
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
λz of AD16
Terminal disposition rate constant/terminal rate constant
Mean retention time(MRT )of AD16
Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity

Secondary Outcome Measures

Ae
The amount of drug excreted in urine at t hours after administration The amount of drug excreted by fecal sample at t hours after administration
Fe0-t
Cumulative excretion rate of drugs through urine Cumulative rate of drug excretion through feces
Renal clearance
Renal clearance of drug from plasma

Full Information

First Posted
March 1, 2023
Last Updated
March 14, 2023
Sponsor
Xiangya Hospital of Central South University
search

1. Study Identification

Unique Protocol Identification Number
NCT05787028
Brief Title
Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Acronym
AD16
Official Title
Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
A single-center, randomized, placebo-controlled, double-blind, dose-increasing study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD16
Arm Type
Experimental
Arm Description
The experimental group received AD16, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day.7 dosing cohorts will receive a single oral dose of AD16.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group received AD16 placebo, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day. 7 dosing cohorts will receive a single oral dose of AD16 placebo.
Intervention Type
Drug
Intervention Name(s)
AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg
Intervention Description
Take one AD16 tablet in the morning
Intervention Type
Drug
Intervention Name(s)
AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg
Intervention Description
Participants will take a placebo pill matching AD16 once in the morning
Primary Outcome Measure Information:
Title
Adverse events
Description
The number of adverse events
Time Frame
day-7 to day3
Title
Serious adverse events
Description
The number of serious adverse events
Time Frame
day-7 to day3
Title
Number of participants with abnormal laboratory test results
Description
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine
Time Frame
Screening period (day-7 to day-2) and day3
Title
Number of participants with abnormal vital signs
Description
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Time Frame
day-7 to day3
Title
Number of participants with abnormal 12-lead electrocardiogram readings
Description
abnormal 12-lead electrocardiogram readings
Time Frame
Screening period (day-7 to day-2) and day3
Title
Number of participants with abnormal physical examination findings
Description
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Time Frame
Screening period (day-7 to day-2) and day3
Title
Concomitant Medication
Description
Any concomitant medication
Time Frame
up to day3
Title
Tmax of AD16
Description
Time to reach the maximum (peak) plasma concentration following drug administration
Time Frame
day1 to day3
Title
Cmax of AD16
Description
Maximum (peak) plasma drug concentration
Time Frame
day1 to day3
Title
t1/2z of AD16
Description
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time Frame
day1 to day3
Title
AUC 0-∞ of AD16
Description
AUC 0-∞ is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). area under curve(AUC)
Time Frame
day1 to day3
Title
AUC 0-t of AD16
Description
AUC 0-t is defined as the concentration of drug from time zero to the last quantifiable concentration.area under curve(AUC)
Time Frame
day1 to day3
Title
CL/F of AD16
Description
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). administration
Time Frame
day1 to day3
Title
Vd/F of AD16
Description
Apparent volume of distribution after non-intravenous administration
Time Frame
day1 to day3
Title
λz of AD16
Description
Terminal disposition rate constant/terminal rate constant
Time Frame
day1 to day3
Title
Mean retention time(MRT )of AD16
Description
Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity
Time Frame
day1 to day3
Secondary Outcome Measure Information:
Title
Ae
Description
The amount of drug excreted in urine at t hours after administration The amount of drug excreted by fecal sample at t hours after administration
Time Frame
day-3 to day3
Title
Fe0-t
Description
Cumulative excretion rate of drugs through urine Cumulative rate of drug excretion through feces
Time Frame
day-3 to day3
Title
Renal clearance
Description
Renal clearance of drug from plasma
Time Frame
day-3 to day3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects were aged 18-45 years (including boundary values), male and female. Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends). Have fully understood this study, voluntarily participated in it, and signed the Informed Consent. Subjects are able to communicate well with researchers and complete the study according to protocol. 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. 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: Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody. 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. A history of postural hypotension with frequent episodes. A history of frequent nausea or vomiting due to any cause. Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study. Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center. Previous drug abuse history or positive urine drug screening during screening period. Smokers who smoked more than 5 cigarettes a day in the 3 months before the test. 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. Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day. Surgical procedures, transfusions of blood or blood components in the month prior to study screening. Blood loss or donation of more than 400 mL in the 2 months prior to screening. Participated in other clinical studies and took experimental drugs within 3 months prior to study screening. Study participants who had received any medication in the 28 days prior to screening. Pregnant or lactating women or women who have had unprotected sex within 14 days. Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.
Facility Information:
Facility Name
The Central South University Xiang Ya Hospital
City
Changsha
Country
China

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration

We'll reach out to this number within 24 hrs