Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
• Treatments: Immunoglobulin Fc Fragments; T0001

Criteria

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;