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CompletedNCT05787028AD16Updated Dec 1, 2023

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

A Phase 1 interventional study of AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg and AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg in Alzheimer's Disease, sponsored by South China Center For Innovative Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by South China Center For Innovative Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Jan 2019, registered Mar 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 70 is close to the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

South China Center For Innovative Pharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    AD16

    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.

    Drug: AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg

  • Placebo comparator
    placebo

    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.

    Drug: AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg

Interventions

  • DrugAD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg

    Take one AD16 tablet in the morning

  • DrugAD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg

    Participants will take a placebo pill matching AD16 once in the morning

06

What researchers measure

Primary outcomes

  1. Adverse events

    The number of adverse events

    Time frame: day-7 to day3

  2. Serious adverse events

    The number of serious adverse events

    Time frame: day-7 to day3

  3. Number of participants with abnormal laboratory test results

    Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine

    Time frame: Screening period (day-7 to day-2) and day3

  4. 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.

    Time frame: day-7 to day3

  5. Number of participants with abnormal 12-lead electrocardiogram readings

    abnormal 12-lead electrocardiogram readings

    Time frame: Screening period (day-7 to day-2) and day3

  6. 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.

    Time frame: Screening period (day-7 to day-2) and day3

  7. Concomitant Medication

    Any concomitant medication

    Time frame: up to day3

  8. Tmax of AD16

    Time to reach the maximum (peak) plasma concentration following drug administration

    Time frame: day1 to day3

  9. Cmax of AD16

    Maximum (peak) plasma drug concentration

    Time frame: day1 to day3

  10. t1/2z of AD16

    Elimination half-life (to be used in a one-compartment or noncompartmental model)

    Time frame: day1 to day3

  11. 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)

    Time frame: day1 to day3

  12. 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)

    Time frame: day1 to day3

  13. CL/F of AD16

    CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). administration

    Time frame: day1 to day3

  14. Vd/F of AD16

    Apparent volume of distribution after non-intravenous administration

    Time frame: day1 to day3

  15. λz of AD16

    Terminal disposition rate constant/terminal rate constant

    Time frame: day1 to day3

  16. Mean retention time（MRT ）of AD16

    Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity

    Time frame: day1 to day3

Secondary outcomes

  1. 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

    Time frame: day-3 to day3

  2. Fe0-t

    Cumulative excretion rate of drugs through urine Cumulative rate of drug excretion through feces

    Time frame: day-3 to day3

  3. Renal clearance

    Renal clearance of drug from plasma

    Time frame: day-3 to day3

07

Study locations

1 site
  • The Central South University Xiang Ya Hospital
    Changsha, China
08

References and documents

Publications

  • 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. PubMed 37996817 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05787028
Lead sponsor
South China Center For Innovative Pharmaceuticals
Collaborators
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Mar 28, 2023
Start date
Jan 30, 2019
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update
Dec 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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