Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Rheumatic Diseases Clinical Trial

Official title:

An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291471
• Other study ID #: T0001-P1.0
• Status: Completed
• Phase: Phase 1
• 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
• 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;

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

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