CompletedPhase 1

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

China48 participantsStarted 2022-11-29

Plain-language summary

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

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male or female participants 18 to 45 years of age.
✓. Body weight ≥ 50 kg ; body mass index of 19 to 28 kg/m\^2 ;
✓. Subjects have no birth plan and voluntarily take effective contraceptive measures within 3 months after signing the informed consent form and the last medication;
✓. Willing and able to sign the informed consent form, and understand and abide by the research procedures.

✕. Allergic constitution or a history of food and drug allergy;
✕. According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation;
✕. 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;
✕. The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant;
✕. HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive;
✕. Pregnant or lactating women;
✕. A History of drug abuse, or positive urine drug abuse screening;
✕. Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period;

Safety and Tolerability

Timeframe: day 11

NCT IDNCT05656274

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-24

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male or female participants 18 to 45 years of age.
✓. Body weight ≥ 50 kg ; body mass index of 19 to 28 kg/m\^2 ;
✓. Subjects have no birth plan and voluntarily take effective contraceptive measures within 3 months after signing the informed consent form and the last medication;
✓. Willing and able to sign the informed consent form, and understand and abide by the research procedures.

✕. Allergic constitution or a history of food and drug allergy;
✕. According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation;
✕. 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;
✕. The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant;
✕. HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive;
✕. Pregnant or lactating women;
✕. A History of drug abuse, or positive urine drug abuse screening;
✕. Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period;