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

NCT00822341 | Completed Phase 1

• 1 other identifier: TG-0054-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

TG-0054 DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• GPCR Therapeutics, Inc.: lead

Study Sites (1)

PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Study Officials

• Ronald Goldwater, M.D.

  PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

US (1)