US Neulasta

COMBINATION_PRODUCT3 trials

Sponsors

Intas Pharmaceuticals, Ltd., Qilu Pharmaceutical Co., Ltd.

Conditions

HealthyHealthy VolunteersImmunogenicityPharmacokinetic Bioequivalence Study in Human Healthy Volunteers

Phase 1

Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.

CompletedNCT04014062

Intas Pharmaceuticals, Ltd.Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers

Start: 2018-02-12End: 2018-05-01Updated: 2019-10-04

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.

CompletedNCT04015232

Intas Pharmaceuticals, Ltd.Healthy Volunteers, Immunogenicity

Start: 2018-02-26End: 2018-06-05Updated: 2019-10-04

A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

Qilu Pharmaceutical Co., Ltd.Healthy

Start: 2020-11-06End: 2022-11-30Target: 300Updated: 2020-12-03