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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822341
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : March 27, 2014
Information provided by:
TaiGen Biotechnology Co., Ltd.

January 13, 2009
January 14, 2009
March 27, 2014
April 2008
May 2009   (Final data collection date for primary outcome measure)
  • 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 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
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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.
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Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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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.
March 2014

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