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OpenTrials
Completed

NCT Number: NCT02291471

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase I laboratory of Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

T0001,10mg

Drug

T0001,20mg

Drug

T0001,35mg

Drug

T0001,50mg

Drug

T0001,65mg

Drug

T0001,75mg

Drug

Primary outcomes

  1. Maximum Tolerance Dose

    Time frame: 3 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 3 weeks

  2. pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2014
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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