Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy adult volunteers, able to give written informed consent for participation in the trial;
Men or women 50% each , aged 18-45 years old;
Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;
Acute or chronic infection, or history of active tuberculosis;
History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
Subjects with a history of mental problems;
Pregnant and lactating women or women who plan to be pregnant in 3 months;
Occurence of clinical significant abnormal laboratory examination value during the screening;
Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols;
Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;