NCT01543971

Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)

Phase I Double-Blinded Comparison Study Using TXA127 and/or Neupogen to Increase Peripheral Blood Stem Cell (CD34+) Counts

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Tarix Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together. The aim of the study is to determine the safety of the TXA127 alone and in combination with Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen enhances peripheral blood stem cell (CD34+)mobilization.

Detailed description

In this double-blinded comparison study, healthy volunteers will be randomized to one of 3 treatment groups: (Group A) TXA127 at 300 mcg/kg once a day for 5 days or (Group B) Neupogen 10 mcg/kg once a day for 5 days or (Group C) both together once a day for 5 days, these treatments administered by subcutaneous injection, to increase peripheral blood stem cell (CD34+) concentrations in healthy volunteers. A minimum of 18 healthy male and female volunteer Subjects (6 in each treatment group) who meet all inclusion and none of the exclusion criteria will be enrolled in this study. Subjects will be recruited from the study center's existing database of healthy volunteers and/or by advertising. A sufficient number of alternate volunteers will be screened and checked-in on Day 0 to ensure 6 eligible healthy volunteers are enrolled on Day 1 in each treatment group. Subjects will remain housed in teh Unit during the conduct of this study. Safety: Predose blood samples will be collected immediately prior to receiving the study medication(s), as well as at 4 hours, 8 hours, 12 hours and 16 hours post-dose.

Conditions

• Miscellaneous Peripheral Blood Cell Abnormalities

Interventions

Type	Name	Description
DRUG	TXA127	TXA127 : 300mcg/kg per day for 5 days, injection
DRUG	Neupogen (filgrastim)	Neupogen : 10mcg/kg per day for 5 days, injection

Timeline

• Start date: 2009-12-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2012-03-05
• Last updated: 2016-08-31

Locations

1 site across 1 country: United States