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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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TG-0054

0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes