Clinical trial NCT05656274: A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects.
Official title: A Phase 1b，Randomized, Investigator/Participant-Blind, Placebo-Controlled, Multiple-Ascending Dose Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of JS1-1-01 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety，tolerability，and pharmacokinetics of multiple-accending dose of JS1-1-01。


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: day 11
Secondary outcomes:
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after a single dose
timeFrame: day 1
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
measure: Pharmacokinetics profile after multiple dosing.
timeFrame: day 11
Other outcomes:
measure: Pharmacodynamics：Concentration of BDNF
timeFrame: day 9
measure: Pharmacodynamics：Changes in heart rate and blood pressure
timeFrame: day 9
measure: Pharmacodynamics：Incidence of AESI
timeFrame: day 11
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: