Safety and Immunogenicity of MSB11455 in Healthy Participants

Fresenius Kabi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: US-Neulasta; Drug: MSB11455

Study type: Interventional

Funder types: Industry

Identifiers

NCT03251339

EMR200621-003

Details and patient eligibility

About

The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.

Enrollment: 336 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who provide signed and dated written informed consent.
• Participants with laboratory test results within predefined ranges.
• Other protocol defined inclusion criteria could apply.

Exclusion criteria

• Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.
• Other protocol defined exclusion criteria could apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 2 patient groups

MSB11455

Experimental group

Description:

Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.

Treatment:

Drug: MSB11455

US-Neulasta

Experimental group

Description:

Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.

Treatment:

Drug: US-Neulasta