Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Fresenius Kabi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Neulasta; Drug: MSB11455

Study type: Interventional

Funder types: Industry

Identifiers

NCT03251248

EMR200621-001

Details and patient eligibility

About

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.

Enrollment: 294 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who provide signed and dated written informed consent
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455, and laboratory test results within predefined ranges
• Other protocol defined exclusion criteria could apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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294 participants in 2 patient groups

First MSB11455 Then Neulasta

Experimental group

Treatment:

Drug: MSB11455

Drug: Neulasta

First Neulasta Then MSB11455

Experimental group

Treatment:

Drug: MSB11455

Drug: Neulasta