Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Rheumatic Diseases

Treatments

Drug: T0001，65mg

Drug: T0001，20mg

Drug: T0001，50mg

Drug: T0001，35mg

Drug: T0001，10mg

Drug: T0001，75mg

Study type

Interventional

Funder types

Industry

Identifiers

T0001-P1.0

Details and patient eligibility

About

The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.

Enrollment

56 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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;

Exclusion criteria

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;