Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Phase 1

Completed

• Conditions: Rheumatic Diseases
• Interventions: Drug: T0001，10mg; Drug: T0001，20mg; Drug: T0001，35mg; Drug: T0001，50mg; Drug: T0001，65mg; Drug: T0001，75mg

• Registration Number: NCT02291471
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T0001	T0001，35mg	-
T0001	T0001，75mg	-
T0001	T0001，50mg	-
T0001	T0001，10mg	-
T0001	T0001，65mg	-
T0001	T0001，20mg	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerance Dose	3 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 weeks
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

Trial Locations

Locations (1)

Phase I laboratory of Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China