Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety，tolerability，and pharmacokinetics of multiple-accending dose of JS1-1-01。
Interventions
DRUGJS1-1-01
Oral tables
DRUGPlacebo
Oral tables
Sponsors
Tasly Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female participants 18 to 45 years of age. 2. Body weight ≥ 50 kg ; body mass index of 19 to 28 kg/m\^2 ; 3. Subjects have no birth plan and voluntarily take effective contraceptive measures within 3 months after signing the informed consent form and the last medication; 4. Willing and able to sign the informed consent form, and understand and abide by the research procedures.
Exclusion criteria
1. Allergic constitution or a history of food and drug allergy; 2. According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation; 3. There are neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, blood and lymphatic, endocrine, skeletal and muscular diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the study; 4. The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant; 5. HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive; 6. Pregnant or lactating women; 7. A History of drug abuse, or positive urine drug abuse screening; 8. Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period; 9. In recent three months, the amount of alcohol consumed per week exceeded 14 units of alcohol , or the alcohol breath test was positive, or alcohol consumption was prohibited from 48 hours before the first administration to the end of the test; 10. Those who have taken any drugs within 4 weeks before the first administration (including prescription drugs, over-the-counter drugs, Chinese herbal medicine, vitamins, calcium tablets and other food supplements); 11. Difficulty in blood collection and history of blood sickness and needle sickness; 12. Those who have special requirements on diet and can not follow the unified diet, or are prone to diarrhea, nausea, vomiting, abdominal distension or other gastrointestinal discomfort after drinking milk or dairy products; 13. From 48 hours before the first administration to the end of the study, the subjects refused to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc; 14. From 7 days before the first administration to the end of the study, the subjects refused to stop using any drink or food containing grapefruit; 15. Participated in any drug clinical trial and took the test drug in recent 3 months; Or those who plan to participate in other clinical trials during the trial 16. Those who have donated blood or lost blood ≥ 200 mL or received blood transfusion or used blood products in recent 3 months; Or those who plan to donate blood during the trial; 17. The researchers believe that the subjects have poor compliance or other clinical, social or family factors that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | day 11 | To evaluate the safety and tolerability of JS1-1-01 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics profile after a single dose | day 1 | Cmax of JS1-1-01 and its major metabolites after a single dose. |
| Pharmacokinetics profile after multiple dosing. | day 11 | Css\_min of JS1-1-01 and its major metabolites after multiple dosing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics：Concentration of BDNF | day 9 | Concentration of BDNF(Brain derived neurotrophic factor) |
| Pharmacodynamics：Changes in heart rate and blood pressure | day 9 | Changes in heart rate and blood pressure (systolic/diastolic) compared with baseline |
| Pharmacodynamics：Incidence of AESI | day 11 | Incidence of AESI（adverse event of special interest） (nausea, dry mouth, headache, sweating, somnolence) |
Countries
China
Outcome results
None listed