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

Tasly Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: JS1-1-01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05656274

TSL-CM-JS1-1-01-Ⅰb

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

JS1-1-01

Experimental group

Description:

JS1-1-01 25mg，50mg，100mg，150mg

Treatment:

Drug: JS1-1-01

Placebo

Placebo Comparator group

Description:

placebo 25mg，50mg，100mg，150mg

Treatment:

Drug: Placebo