A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects.

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656274
• Other study ID #: TSL-CM-JS1-1-01-?b
• Status: Recruiting
• Phase: Phase 1
• Start date: November 29, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2022
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: HuaFang Li, Doctor
• Phone: 18017311256
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• JS1-1-01
Oral tables
• Placebo
Oral tables

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	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)	1 Month