Alzheimer DiseasePhase 1MADNCT05806177
Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects
A Phase 1 study testing AD16 30mg、40mg in people with Alzheimer Disease, run by South China Center For Innovative Pharmaceuticals at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AD16 30mg、40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2020to 31 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects
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.
Read the detailed description
In this study, subjects were given multiple doses in the corresponding dose group
- Conditions
- Alzheimer Disease
- Being tested
- AD16 30mg、40mg, AD16 Placebo 30mg、40mg
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD16 30mg、40mgDrug
AD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
AD16 Placebo 30mg、40mgDrug
AD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AD16 30mg、40mg |
| 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. Receives: Drug: AD16 Placebo 30mg、40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The number of adverse events
Measured: day-7 to day11
Serious adverse events
The number of serious adverse events
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Screening period（day-7 to day-2）、days11
Concomitant medication
Any concomitant medication
Measured: Up to day 11
Secondary outcomes (21)
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
Measured: Up to day 11
Cmax of AD16
Maximum (peak) plasma drug concentration
Measured: Up to day 11
t1/2z of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Measured: Up to day 11
AUC 0-∞ of AD16
Area under the plasma concentration-time curve（AUC） from time zero to infinity
Measured: Up to day 11
AUC 0-t of AD16
Area under the plasma concentration-time curve（AUC） from time zero to time t
Measured: Up to day 11
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
Measured: Up to day 11
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Measured: Up to day 11
λz of AD16
Terminal disposition rate constant/terminal rate constant
Measured: Up to day 11
AUC 0-48h of AD16
Area under the plasma concentration-time curve from time zero to time 48h
Measured: Up to day 11
AUC_%Extrap of AD16
AUC_%Extrap is residual area percentage
Measured: Up to day 11
Tmax,ss of AD16
Time to reach the maximum (peak) plasma concentration following drug administration at steady state
Measured: Up to day 11
Cmax, ss of AD16
Maximum (peak) steady-state plasma drug concentration during a dosage interval
Measured: Up to day 11
Cavg,ss of AD16
Cavg,ss is the steady-state mean concentration
Measured: Up to day 11
t1/2,ss of AD16
Elimination half-life（steady state ）
Measured: 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
Measured: Up to day 11
AUC 0-48h,ss of AD16
Area under the plasma concentration-time curve from the last dose to 48 h
Measured: 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
Measured: 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 ）
Measured: Up to day 11
Rac of AD16
Rac is accumulation ratio
Measured: Up to day 11
DF of AD16
Degree of fluctuation（DF）Percentage fluctuation in steady state = 100 × (Cmax,ss -Cmin,ss)/Cavg,ss
Measured: Up to day 11
Vd/F,ss of AD16
Apparent volume of distribution after non-intravenous administration （steady state ）
Measured: Up to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start26 May 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- South China Center For Innovative Pharmaceuticals
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806177
- Sponsor's protocol ID
- SCCIP-AD16-2018-03
- Acronym
- MAD
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT05806177
- Acronym / sponsor ID
- MAD / SCCIP-AD16-2018-03
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- South China Center For Innovative PharmaceuticalsUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- 26 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design
| Arm | Type | Receives |
|---|---|---|
| AD16 | Experimental | Drug: AD16 30mg、40mgAD16 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 | Drug: AD16 Placebo 30mg、40mgAD16 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD16 30mg、40mgAD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study | Drug | AD16 |
| AD16 Placebo 30mg、40mgAD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study | Drug | AD16 placebo |
Primary outcome
Adverse events
Time frame: day-7 to day11
The number of adverse events
Serious adverse events
Time frame: day-7 to day11
The number of serious adverse events
Number of participants with abnormal laboratory test results
Time frame: Screening period (day-7 to day-2) and day11
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine, etc.
Number of participants with abnormal vital signs
Time frame: Screening period（day-7 to day-1）、days1、4、5、6、8、9
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
Time frame: Screening period（day-7 to day-2）、days1、6、11
Abnormal12-lead electrocardiogram
Number of participants with abnormal physical examination findings
Time frame: Screening period（day-7 to day-2）、days11
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
Time frame: Up to day 11
Any concomitant medication
21 secondary outcomes
Tmax of AD16
Time frame: Up to day 11
Cmax of AD16
Time frame: Up to day 11
t1/2z of AD16
Time frame: Up to day 11
AUC 0-∞ of AD16
Time frame: Up to day 11
AUC 0-t of AD16
Time frame: Up to day 11
Vd/F of AD16
Time frame: Up to day 11
CL/F of AD16
Time frame: Up to day 11
λz of AD16
Time frame: Up to day 11
AUC 0-48h of AD16
Time frame: Up to day 11
AUC_%Extrap of AD16
Time frame: Up to day 11
Tmax,ss of AD16
Time frame: Up to day 11
Cmax, ss of AD16
Time frame: Up to day 11
Cavg,ss of AD16
Time frame: Up to day 11
t1/2,ss of AD16
Time frame: Up to day 11
AUC 0-τ,ss of AD16
Time frame: Up to day 11
AUC 0-48h,ss of AD16
Time frame: Up to day 11
AUC 0-∞,ss of AD16
Time frame: Up to day 11
CL/F,ss of AD16
Time frame: Up to day 11
Rac of AD16
Time frame: Up to day 11
DF of AD16
Time frame: Up to day 11
Vd/F,ss of AD16
Time frame: Up to day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 37996817Peng 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD16 30mg、40mg in people with Alzheimer Disease, run by South China Center For Innovative Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: day-7 to day11). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.