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AD16

CompletedPhase 1

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

Asset

AD16

Listed sites

1

Recruiting sites

-

Enrollment

70

actual

Study population

Alzheimer’s disease

Key I/E criterion

Healthy volunteers

Primary endpoints

Adverse eventsSerious adverse eventsAbnormal laboratory test results

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05787028
Org study IDSCCIP-AD16-2018-01

Timeline

Milestones

Study start2019-01-30actual
Primary completion2020-05-31actual
Study completion2020-05-31actual
Study first posted2023-03-28actual
Last update posted2023-12-01actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
9
Other (unclassified)
9
Other clinical outcomes
1

Safety / tolerability / PK

9 endpoints
Primary/protocol endpoint

Adverse events

Time frame:day-7 to day3

event count, event

Primary/protocol endpoint

Serious adverse events

Time frame:day-7 to day3

event count, event

Primary/protocol endpoint

Number of participants with abnormal vital signs

Time frame:day-7 to day3

event count, event

Primary/protocol endpoint

Number of participants with abnormal 12-lead electrocardiogram readings

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

event count, event

Primary/protocol endpoint

Tmax of AD16

Time frame:day1 to day3

time to event, event

Primary/protocol endpoint

Cmax of AD16

Time frame:day1 to day3

concentration, descriptive

Primary/protocol endpoint

t1/2z of AD16

Time frame:day1 to day3

concentration, descriptive

Primary/protocol endpoint

AUC 0-∞ of AD16

Time frame:day1 to day3

concentration, descriptive

Primary/protocol endpoint

AUC 0-t of AD16

Time frame:day1 to day3

concentration, descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Mean retention time(MRT )of AD16

Time frame:day1 to day3

descriptive

Other (unclassified)

9 endpoints
Primary/protocol endpoint/low confidence

Number of participants with abnormal laboratory test results

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

event count, event

Primary/protocol endpoint/low confidence

Number of participants with abnormal physical examination findings

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

event count, event

Primary/protocol endpoint/low confidence

Concomitant Medication

Time frame:up to day3

descriptive

Primary/protocol endpoint/low confidence

CL/F of AD16

Time frame:day1 to day3

ratio, descriptive

Primary/protocol endpoint/low confidence

Vd/F of AD16

Time frame:day1 to day3

ratio, descriptive

Primary/protocol endpoint/low confidence

λz of AD16

Time frame:day1 to day3

descriptive

Secondary/protocol endpoint/low confidence

Ae

Time frame:day-3 to day3

ratio, descriptive

Secondary/protocol endpoint/low confidence

Fe0-t

Time frame:day-3 to day3

descriptive

Secondary/protocol endpoint/low confidence

Renal clearance

Time frame:day-3 to day3

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.