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

Last updated: November 17, 2024
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

JS1-1-01

Placebo

Clinical Study ID

NCT05656274
TSL-CM-JS1-1-01-Ⅰb
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 measureswithin 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 theresearch procedures.

Exclusion

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 suiciderisk , 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 kidneydysfunction, or any other diseases and physiological conditions that may affect thestudy;

  4. The results of vital signs, physical examination, electrocardiogram and laboratoryexamination are abnormal and clinically significant;

  5. HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody werepositive;

  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 completelyquitting smoking during the study period;

  9. In recent three months, the amount of alcohol consumed per week exceeded 14 units ofalcohol , or the alcohol breath test was positive, or alcohol consumption wasprohibited 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, orare prone to diarrhea, nausea, vomiting, abdominal distension or othergastrointestinal discomfort after drinking milk or dairy products;

  13. From 48 hours before the first administration to the end of the study, the subjectsrefused 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 subjectsrefused 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 orused blood products in recent 3 months; Or those who plan to donate blood during thetrial;

  17. The researchers believe that the subjects have poor compliance or other clinical,social or family factors that are not suitable for inclusion.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: JS1-1-01
Phase: 1
Study Start date:
November 29, 2022
Estimated Completion Date:
July 24, 2023

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai,
    China

    Site Not Available

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