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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.

NCT04015232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-10-04

Study results available
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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

COMBINATION_PRODUCT

INTP5

INTP5, a pegfilgrastim biosimilar to US Neulasta.

COMBINATION_PRODUCT

US Neulasta

US Neulasta: FDA approved pegfilgrastim innovator product.

Sponsors & Collaborators

  • Lambda Therapeutic Research Ltd.

    collaborator INDUSTRY

  • Intas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Adarsh K Garg, M.B.B.S · Lambda Therapeutic Research Ltd.

  • Vinu Jose, M.D. · Intas Pharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-06-05
Completion
2018-06-05
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015232 on ClinicalTrials.gov