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Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00822341
First received: January 13, 2009
Last updated: November 23, 2009
Last verified: November 2009
History of Changes

January 13, 2009
November 23, 2009
April 2008
Not Provided
  • To assess the safety and tolerability for a single IV dose of TG-0054
  • To determine the maximum tolerated dose (MTD) of TG-0054
Same as current
Complete list of historical versions of study NCT00822341 on ClinicalTrials.gov Archive Site
  • To assess the plasma pharmacokinetics (PK) profile of TG-0054
  • To assess the pharmacodynamic (PD) effects of TG-0054 via CD34+stem cell, CD133+ progenitor cell counts; white blood cell (WBC), red blood cell (RBC), platelet, and differential counts
Same as current
Not Provided
Not Provided
 
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Single Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TG-0054 in Healthy Subjects

TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
Drug: TG-0054
0.1, 0.2, 0.4, 0.8, 1.6, and 3.2 mg/kg of TG-0054/placebo via 15 min IV infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
Not Provided

Inclusion Criteria:

  • Healthy male or female 18 to 45 years of age inclusive
  • Body mass index (BMI) in the range of 19.0 to 30.0 kg/m² and body weight ≥ 50 kg inclusive
  • Good physical and mental health status determined on the basis of the medical history and a general clinical examination
  • Subjects must have used a consistent form of acceptable oral birth control or the double barrier method (intrauterine device (IUD) plus condom, spermicidal gel plus condom) for at least 3 months prior to study initiation

Exclusion Criteria:

  • Any medical condition (other than a self-limited illness) that requires ongoing and current medical attention
  • History of any other hematologic disorders including thromboembolic disease or anemia
  • Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  • Subjects who currently smoke (intake nicotine or nicotine-containing products) or have given up smoking for less than 6 months before the first administration of study drug
  • Subjects who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody or who are Human Immunodeficiency Virus (HIV) antibody positive
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822341
TG-0054-01
Not Provided
Hao Zhang M.D, Medical Director, TaiGen Biotechnology Co., Ltd.
TaiGen Biotechnology Co., Ltd.
Not Provided
Principal Investigator: Ronald Goldwater, M.D. PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center
TaiGen Biotechnology Co., Ltd.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP