Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01543971
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2010-02-10
Brief Title:
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells PBSCs
Sponsor:
Tarix Pharmaceuticals
Organization:
Tarix Pharmaceuticals
Study Overview
Official Title:
Phase I Double-Blinded Comparison Study Using TXA127 andor Neupogen to Increase Peripheral Blood Stem Cell CD34 Counts
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CD34mobilization
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 CD34mobilization
Detailed Description:
In this double-blinded comparison study healthy volunteers will be randomized to one of 3 treatment groups Group A TXA127 at 300 mcgkg once a day for 5 days or Group B Neupogen 10 mcgkg 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 centers existing database of healthy volunteers andor 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 medications as well as at 4 hours 8 hours 12 hours and 16 hours post-dose
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 centers existing database of healthy volunteers andor 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 medications as well as at 4 hours 8 hours 12 hours and 16 hours post-dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None