NCT04015232

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.

An Assessor-blind, Balanced, Parallel, Randomized, Two-treatment, Comparative Immunogenicity Study of Multiple Doses of INTP5 of Intas Pharmaceuticals Limited, India Against Neulasta® of Amgen Inc., USA Administered Subcutaneously in Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Intas Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd. proposed biosimilar INTP5 compared to innovator product, US-Neulasta) in healthy, adult, human subjects under fed conditions.

Conditions

• Immunogenicity
• Healthy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	INTP5	INTP5, a pegfilgrastim biosimilar to US Neulasta.
COMBINATION_PRODUCT	US Neulasta	US Neulasta: FDA approved pegfilgrastim innovator product.

Timeline

• Start date: 2018-02-26
• Primary completion: 2018-06-05
• Completion: 2018-06-05
• First posted: 2019-07-10
• Last updated: 2019-10-04
• Results posted: 2019-10-04

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study