Safety, Tolerability and Pharmacokinetics of AD16 Tablets After MAD in Healthy Chinese Adult Subjects

NCT05806177 | Completed Phase 1

• 1 other identifier: SCCIP-AD16-2018-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 40mg groups.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (21)

• Tmax of AD16

  Up to day 11

• Cmax of AD16

  Up to day 11

• t1/2z of AD16

  Up to day 11

• AUC 0-∞ of AD16

  Up to day 11

• AUC 0-t of AD16

  Up to day 11

Study Arms (2)

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.

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.

Drug: AD16 Placebo 30mg、40mg

Interventions

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

AD16

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

AD16 placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• South China Center For Innovative Pharmaceuticals: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The Central South University Xiang Ya Hospital

Changsha, China

Location

Related Publications (1)

• 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.

  PMID: 37996817 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, placebo-controlled, double-blind, dose-increasing study design

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 10, 2023
• Study Start: May 26, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

CN (1)