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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014