Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00822341
- Lead Sponsor
- GPCR Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 To assess the plasma pharmacokinetics (PK) profile of TG-0054
Trial Locations
- Locations (1)
PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States