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: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Healthy
Drug: TG-0054
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by TaiGen Biotechnology Co., Ltd.:

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

Secondary Outcome Measures:
  • 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

Enrollment: 64
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822341

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

No publications provided

Responsible Party: Hao Zhang M.D, Medical Director, TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT00822341     History of Changes
Other Study ID Numbers: TG-0054-01
Study First Received: January 13, 2009
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014