At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 200 enrolled
Drug / intervention
INTP5 +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating INTP5 and US Neulasta for Immunogenicity and Healthy Volunteers. Completed, enrolled 200 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunogenicity, Healthy Volunteers
CountriesIndia
CollaboratorsLambda Therapeutic Research Ltd.
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
Primary CompletionJun 2018
First PostedJul 2019
TodayJul 2026
First PostedJul 10, 2019
Enrollment StartFeb 26, 2018
Primary CompletionJun 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.0 years ago
Interventions
INTP5combination
INTP5, a pegfilgrastim biosimilar to US Neulasta.
US Neulastacombination
US Neulasta: FDA approved pegfilgrastim innovator product.