Status:
COMPLETED
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Rheumatic Diseases
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02291471
Start Date
October 1 2014
End Date
February 1 2015
Last Update
July 9 2019
Active Locations (1)
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1
Phase I laboratory of Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044