Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

NCT02291471 | Completed Phase 1

• 1 other identifier: T0001-P1.0
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerance Dose

  3 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

T0001

EXPERIMENTAL

Drug: T0001，10mg; Drug: T0001，20mg; Drug: T0001，35mg; Drug: T0001，50mg; Drug: T0001，65mg; Drug: T0001，75mg

Interventions

T0001，10mg DRUG

T0001

T0001，20mg DRUG

T0001

T0001，35mg DRUG

T0001

T0001，50mg DRUG

T0001

T0001，65mg DRUG

T0001

T0001，75mg DRUG

T0001

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Phase I laboratory of Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wang wei

  Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

• Fang Yi, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

CN (1)