Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Drug: T0001，10mg; Drug: T0001，20mg; Drug: T0001，35mg; Drug: T0001，50mg; Drug: T0001，65mg; Drug: T0001，75mg

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Phase I laboratory of Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T0001	Drug: T0001，10mg; Drug: T0001，20mg; Drug: T0001，35mg; Drug: T0001，50mg; Drug: T0001，65mg; Drug: T0001，75mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerance Dose	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Investigators: Study Director: wang wei, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Principal Investigator: Fang Yi, Ph.D, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 11, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases; Physiological Effects of Drugs; Antirheumatic Agents; Immunologic Factors; T0001; Immunoglobulin Fc Fragments
• Other Study ID Numbers: T0001-P1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No