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.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: TG-0054 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Intervention Details:
    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

Primary Outcome Measures :
  1. To assess the safety and tolerability for a single IV dose of TG-0054
  2. To determine the maximum tolerated dose (MTD) of TG-0054

Secondary Outcome Measures :
  1. To assess the plasma pharmacokinetics (PK) profile of TG-0054
  2. 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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822341

United States, Maryland
PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Principal Investigator: Ronald Goldwater, M.D. PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center

Responsible Party: Hao Zhang M.D, Medical Director, TaiGen Biotechnology Co., Ltd. Identifier: NCT00822341     History of Changes
Other Study ID Numbers: TG-0054-01
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014