Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03202927
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2017-04-25
Brief Title:
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta in Healthy Adult Subjects
Sponsor:
Adello Biologics LLC
Organization:
Adello Biologics LLC
Study Overview
Official Title:
A Randomized Single Blind Repeat-dose Two Cycle Parallel-Arm Comparative Immunogenicity Study Comparing TPI-120 to Neulasta in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-07
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:
TPI-120
Brief Summary:
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
Detailed Description:
Healthy subjects have been selected as the study population for this comparative study because this population is more homogenous with respect to immune response and offers significant advantages with regards to recruitment and logistical aspects This study will comprise of two cycles with each cycles will have a single dose of PEG FILGRASTIM administration to all study subjects as per the randomization schedule Subjects will be confined from at least 10 hours prior to dosing at the time indicated by the CRU until 36 hours post-dose on day 2 in each Cycle Dosing in each Cycle are separated by 21 days
Subjects will return for all subsequent blood draws and ADA assessments as indicated in The Schedule of Event
Subjects will return for all subsequent blood draws and ADA assessments as indicated in The Schedule of Event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None