Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 12:14 PM
Study NCT ID:
NCT04015232
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Sponsor:
Intas Pharmaceuticals, Ltd.
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2018-02-26
Start Date Type:
ACTUAL
Primary Completion Date:
2018-06-05
Primary Completion Date Type:
ACTUAL
Completion Date:
2018-06-05
Completion Date Type:
ACTUAL
First Submit Date:
2019-07-08
First Submit QC Date:
None
Study First Post Date:
2019-07-10
Study First Post Date Type:
ACTUAL
Results First Submit Date:
2019-07-19
Results First Submit QC Date:
None
Results First Post Date:
2019-10-04
Results First Post Date Type:
ACTUAL
Results First Post QC Date:
None
Results First Post QC Date Type:
None
Disp First Submit Date:
None
Disp First Submit QC Date:
None
Disp First Post Date:
None
Disp First Post Date Type:
None
Last Update Submit Date:
2019-09-13
Last Update Post Date:
2019-10-04
Last Update Post Date Type:
ACTUAL