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AD16
CompletedPhase 1Safety, 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 events•Serious adverse events•Abnormal 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsAdverse events
Time frame:day-7 to day3
event count, event
Serious adverse events
Time frame:day-7 to day3
event count, event
Number of participants with abnormal vital signs
Time frame:day-7 to day3
event count, event
Number of participants with abnormal 12-lead electrocardiogram readings
Time frame:Screening period (day-7 to day-2) and day3
event count, event
Tmax of AD16
Time frame:day1 to day3
time to event, event
Cmax of AD16
Time frame:day1 to day3
concentration, descriptive
t1/2z of AD16
Time frame:day1 to day3
concentration, descriptive
AUC 0-∞ of AD16
Time frame:day1 to day3
concentration, descriptive
AUC 0-t of AD16
Time frame:day1 to day3
concentration, descriptive
Other clinical outcomes
1 endpointMean retention time(MRT )of AD16
Time frame:day1 to day3
descriptive
Other (unclassified)
9 endpointsNumber of participants with abnormal laboratory test results
Time frame:Screening period (day-7 to day-2) and day3
event count, event
Number of participants with abnormal physical examination findings
Time frame:Screening period (day-7 to day-2) and day3
event count, event
Concomitant Medication
Time frame:up to day3
descriptive
CL/F of AD16
Time frame:day1 to day3
ratio, descriptive
Vd/F of AD16
Time frame:day1 to day3
ratio, descriptive
λz of AD16
Time frame:day1 to day3
descriptive
Ae
Time frame:day-3 to day3
ratio, descriptive
Fe0-t
Time frame:day-3 to day3
descriptive
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.
Registry references + supporting bibliography
- PMID37996817via DERIVED
Provenance
Sources
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.