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| Name | Class |
|---|---|
| Xiangya Hospital of Central South University | OTHER |
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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.
In this study, subjects were given multiple doses in the corresponding dose group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD16 | Experimental | AD16 tablets should be administered only in the morning on the day of the first dose and on the ninth day after the first dose. Fasting is required for at least 10 h before administration.Two dosing cohorts received AD16 From the third day to the eighth day, the medicine was administered twice a day, 1 h before breakfast, 1 h before dinner or 2 h after dinner, with a 12 h interval (time window ±1 h).The duration of oral AD16 tablets was nine days. |
|
| AD16 placebo | Placebo Comparator | AD16 placebo tablets should be administered only in the morning on the day of the first dose and on the ninth day after the first dose. Fasting is required for at least 10 h before administration.Two dosing cohorts received AD16 placebo From the third day to the eighth day, the medicine was administered twice a day, 1 h before breakfast, 1 h before dinner or 2 h after dinner, with a 12 h interval (time window ±1 h).The duration of oral AD16 placebo tablets was nine days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD16 30mg、40mg | Drug | AD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The number of adverse events | day-7 to day11 |
| Serious adverse events | The number of serious adverse events | day-7 to day11 |
| Number of participants with abnormal laboratory test results | Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine, etc. | Screening period (day-7 to day-2) and day11 |
| 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. | Screening period(day-7 to day-1)、days1、4、5、6、8、9 |
| Number of participants with abnormal 12-lead electrocardiogram readings | Abnormal12-lead electrocardiogram | Screening period(day-7 to day-2)、days1、6、11 |
| 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. | Screening period(day-7 to day-2)、days11 |
| Concomitant medication | Any concomitant medication | Up to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of AD16 | Time to reach the maximum (peak) plasma concentration following drug administration | Up to day 11 |
| Cmax of AD16 | Maximum (peak) plasma drug concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central South University Xiang Ya Hospital | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37996817 | Derived | Peng D, Xu S, Zou T, Wang Y, Ouyang W, Zhang Y, Dong C, Li D, Guo J, Shen Q, Hu X, Zhou W, Li X, Qin Q. Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. BMC Med. 2023 Nov 23;21(1):459. doi: 10.1186/s12916-023-03126-9. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design
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| AD16 Placebo 30mg、40mg | Drug | AD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study |
|
| Up to day 11 |
| t1/2z of AD16 | Elimination half-life (to be used in a one-compartment or noncompartmental model) | Up to day 11 |
| AUC 0-∞ of AD16 | Area under the plasma concentration-time curve(AUC) from time zero to infinity | Up to day 11 |
| AUC 0-t of AD16 | Area under the plasma concentration-time curve(AUC) from time zero to time t | Up to day 11 |
| Vd/F of AD16 | Apparent volume of distribution after non-intravenous administration | Up to day 11 |
| CL/F of AD16 | CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). | Up to day 11 |
| λz of AD16 | Terminal disposition rate constant/terminal rate constant | Up to day 11 |
| AUC 0-48h of AD16 | Area under the plasma concentration-time curve from time zero to time 48h | Up to day 11 |
| AUC_%Extrap of AD16 | AUC_%Extrap is residual area percentage | Up to day 11 |
| Tmax,ss of AD16 | Time to reach the maximum (peak) plasma concentration following drug administration at steady state | Up to day 11 |
| Cmax, ss of AD16 | Maximum (peak) steady-state plasma drug concentration during a dosage interval | Up to day 11 |
| Cavg,ss of AD16 | Cavg,ss is the steady-state mean concentration | Up to day 11 |
| t1/2,ss of AD16 | Elimination half-life(steady state ) | Up to day 11 |
| AUC 0-τ,ss of AD16 | The area under the plasma concentration-time curve during a dosing interval at steady state | Up to day 11 |
| AUC 0-48h,ss of AD16 | Area under the plasma concentration-time curve from the last dose to 48 h | Up to day 11 |
| AUC 0-∞,ss of AD16 | The area under the plasma concentration-time curve is extrapolated from the last dose to infinity | Up to day 11 |
| CL/F,ss of AD16 | CL/F is defined as the ratio of total clearance(CL) to bioavailability(F)(steady state ) | Up to day 11 |
| Rac of AD16 | Rac is accumulation ratio | Up to day 11 |
| DF of AD16 | Degree of fluctuation(DF)Percentage fluctuation in steady state = 100 × (Cmax,ss -Cmin,ss)/Cavg,ss | Up to day 11 |
| Vd/F,ss of AD16 | Apparent volume of distribution after non-intravenous administration (steady state ) | Up to day 11 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |