Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers

GPCR Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: TG-0054

Study type

Interventional

Funder types

Industry

Identifiers

NCT00822341

TG-0054-01

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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