Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
This study has been completed.
Sponsor:
TaiGen Biotechnology Co., Ltd.
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
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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
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2008 |
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: | November 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 21, 2013