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Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

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ClinicalTrials.gov Identifier: NCT02291471
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Drug: T0001,10mg Drug: T0001,20mg Drug: T0001,35mg Drug: T0001,50mg Drug: T0001,65mg Drug: T0001,75mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: T0001 Drug: T0001,10mg
Drug: T0001,20mg
Drug: T0001,35mg
Drug: T0001,50mg
Drug: T0001,65mg
Drug: T0001,75mg



Primary Outcome Measures :
  1. Maximum Tolerance Dose [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 3 weeks ]
  2. pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc) [ Time Frame: Pre-dose,2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291471


Locations
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China, Beijing
Phase I laboratory of Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Investigators
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Study Director: Wang wei Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Principal Investigator: Fang Yi, Ph.D Peking University People's Hospital
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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02291471    
Other Study ID Numbers: T0001-P1.0
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
T0001
Immunoglobulin Fc Fragments
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs