Back to resultsTolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Primary Purpose
Rheumatic Diseases
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
T0001，10mg
T0001，20mg
T0001，35mg
T0001，50mg
T0001，65mg
T0001，75mg
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Diseases
Eligibility 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;
Sites / Locations
- Phase I laboratory of Peking University People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T0001
Arm Description
Outcomes
Primary Outcome Measures
Maximum Tolerance Dose
Secondary Outcome Measures
Adverse events
pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc）
Full Information
NCT ID
NCT02291471
First Posted
November 11, 2014
Last Updated
July 5, 2019
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02291471
Brief Title
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Official Title
An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T0001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
T0001，10mg
Intervention Type
Drug
Intervention Name(s)
T0001，20mg
Intervention Type
Drug
Intervention Name(s)
T0001，35mg
Intervention Type
Drug
Intervention Name(s)
T0001，50mg
Intervention Type
Drug
Intervention Name(s)
T0001，65mg
Intervention Type
Drug
Intervention Name(s)
T0001，75mg
Primary Outcome Measure Information:
Title
Maximum Tolerance Dose
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
3 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang wei
Organizational Affiliation
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fang Yi, Ph.D
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phase I laboratory of Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Learn more about this trial
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
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