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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822341

Enrollment

Registered

2009-01-14

Start date

2008-04-30

Completion date

2009-05-31

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGTG-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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026