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

Sponsor
GPCR Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00822341
Collaborator
(none)
64
Enrollment
1
Location
13
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

Outcome Measures

Primary Outcome Measures

  1. To assess the safety and tolerability for a single IV dose of TG-0054 []

  2. To determine the maximum tolerated dose (MTD) of TG-0054 []

Secondary Outcome Measures

  1. To assess the plasma pharmacokinetics (PK) profile of TG-0054 []

  2. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center Baltimore Maryland United States 21225

Sponsors and Collaborators

  • GPCR Therapeutics, Inc.

Investigators

  • Principal Investigator: Ronald Goldwater, M.D., PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GPCR Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00822341
Other Study ID Numbers:
  • TG-0054-01
First Posted:
Jan 14, 2009
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021

Study Results

No Results Posted as of Aug 4, 2021