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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00822341

Run by

GPCR Therapeutics, Inc.

People needed

64

Starts

2008-04-01

Expected to finish

2009-05-01

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.