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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02291471
Other study ID # T0001-P1.0
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2014
Est. completion date February 2015

Study information

Verified date July 2019
Source Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
T0001,10mg

T0001,20mg

T0001,35mg

T0001,50mg

T0001,65mg

T0001,75mg


Locations

Country Name City State
China Phase I laboratory of Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerance Dose 3 weeks
Secondary Adverse events 3 weeks
Secondary pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc) 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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