Alzheimers disease/ Bipolar disorder
Conditions
Interventions
Single Ascending Dose(SAD):AY-1001, placebo, or active control drug administered orally once daily.
Multiple Ascending Dose(MAD):AY-1001 or placebo administered orally three times daily.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)??
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Healthy Adult Subjects: 1.Informed Consent??: Fully understand the trial's content, procedures, and potential adverse reactions before the trial; volunteer to participate and provide signed informed consent; 2.Age and Ethnicity??: Chinese healthy adult subjects: Age >= 18 years and = 50.0 kg, female body weight >= 45.0 kg. Body Mass Index [BMI = body weight (kg) / height^2 (m^2)] must be within the range of 19.0 to 26.0 kg/m^2 (inclusive of critical values); 4.Compliance??: Subjects are able to communicate well with the investigator and understand and comply with all requirements of this study. Inclusion Criteria for Healthy Elderly Subjects: 1.??Informed Consent??: Fully understand the trial's content, procedures, and potential adverse reactions before the trial; volunteer to participate and provide signed informed consent; 2.Age and Ethnicity??: Chinese healthy elderly subjects: Age >= 60 years and = 50.0 kg, female body weight >= 45.0 kg; Body Mass Index [BMI = body weight (kg) / height^2 (m^2)] must be within the range of 20.0 to 26.0 kg/m^2 (inclusive of critical values); 4.Independence??: Life self-care or basic self-care; 5.??Organ Function??: No significant functional abnormalities caused by age-related changes in important organs; 6.??Risk Factors??: Risk factors affecting health are controlled within a range appropriate for their age; 7.Nutritional Status??: Good nutritional status; 8.??Cognitive Function??: Basically normal cognitive function; 9.Mental Status??: Optimistic, positive, and self-satisfied; 10.Health Literacy??: Possess certain health literacy and maintain a good lifestyle; 11.Social Participation??: Actively participate in family and social activities; 12.??Social Adaptation??: Good social adaptation ability; 13.Compliance??: Subjects are able to communicate well with the investigator and understand and comply with all requirements of this study; Subjects who do not meet any one of the above criteria shall not be enrolled.?
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Healthy Adult Subjects: 1.Subjects with ??abnormal and clinically significant findings?? during screening, as judged by the investigator, in physical examination, laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation panel, thyroid function tests), vital signs, abdominal ultrasound, or thyroid ultrasound; 2.Subjects with ??abnormal 12-lead ECG?? findings during screening, or with a ??family history of heart failure or sudden death??; 3.Subjects with a ??history of drug abuse?? (non-medical use of any narcotics or psychoactive substances) prior to enrollment, or with a ??positive drug abuse screening?? (including for morphine, methamphetamine, ketamine, MDMA, THC, etc.); 4.Subjects with ??any clinically significant abnormal result?? in serological virology tests (including HIV antibody, HCV antibody, HBsAg, Treponema pallidum antibody) prior to enrollment; 5.Subjects with a ??specific history of allergy?? (e.g., urticaria), or being ??allergic constitution?? (e.g., known allergy to two or more drugs), or with ??known allergy to wheat, AY-1001, or any other ingredient of lithium carbonate??; 6.Subjects with a ??history of orthostatic hypotension, needle phobia, blood phobia, or intolerance to venipuncture and blood sampling; 7.Subjects with a ??history of Parkinson's syndrome??; 8.Subjects with ??current or past history of psychiatric disorders and brain dysfunction??, subjects ??at risk of suicide?? (as judged by the investigator or based on suicidal risk assessment), or with a ??history of self-harm behavior??; 9.Subjects with ??current or past history of organic brain diseases or severe somatic diseases??; 10.Subjects with a ??history of diseases?? involving the cardiovascular, endocrine, urinary, nervous, hematopoietic, immune systems (including personal or family history of hereditary immunodeficiency), psychiatric disorders, metabolic abnormalities, malignant tumors, lymphoproliferative diseases, etc., which are ??still considered clinically significant by the investigator??, or any other condition that the investigator believes may affect the trial results or subject safety; 11.Subjects with ??current/past history of gastrointestinal diseases?? such as esophageal diseases, atrophic gastritis, enteritis, gastrointestinal perforation, or gastrointestinal surgery, which are ??still considered clinically significant by the investigator??; 12.??Excessive alcohol consumption?? within 3 months prior to screening: defined as daily alcohol intake >25g for males or >15g for females; or ??positive alcohol breath test?? (>0.0 mg/100mL); or ??inability to abstain from alcohol during the trial period??; 13.Subjects who consumed ??excessive tea, coffee, and/or caffeine-containing beverages?? (average >8 cups per day, 1 cup ˜ 250mL) within one year prior to screening; 14.Subjects who experienced the following within ??6 months prior to screening??: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack; or with histories of angina pectoris, bradycardia, heart block, etc; 15.Subjects who underwent ??surgery within 6 months prior to screening??, ??especially surgeries that may affect drug absorption, distribution, metabolism, or excretion??, or who plan to undergo surgery during the study; 16.Subjects who ??participated in other drug or medical device clinical trials?? and receiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Clinical laboratory inspection;Vital signs;12-lead electrocardiogram;Health checkup; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Multiple-dose pharmacokinetic parameters;Urinary Pharmacokinetic Parameters; | — |
Countries
China
Contacts
Public ContactShi Jiong/ Yang Zhaoyi
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)??
Outcome results
None listed