NCT04015232View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 26, 2018

Primary Completion Date

June 5, 2018

Study Completion Date

June 5, 2018

Conditions
ImmunogenicityHealthy Volunteers
Interventions
COMBINATION_PRODUCT

INTP5

INTP5, a pegfilgrastim biosimilar to US Neulasta.

COMBINATION_PRODUCT

US Neulasta

US Neulasta: FDA approved pegfilgrastim innovator product.

Trial Locations (1)

382481

Lambda Therapeutic Research Ltd., Ahmedabad

Sponsors
All Listed Sponsors
collaborator

Lambda Therapeutic Research Ltd.

INDUSTRY

lead

Intas Pharmaceuticals, Ltd.

INDUSTRY