NCT03251339

Safety and Immunogenicity of MSB11455 in Healthy Participants

A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Fresenius Kabi SwissBioSim GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MSB11455	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.
DRUG	US-Neulasta	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.

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-02-05
• Completion: 2018-09-22
• First posted: 2017-08-16
• Last updated: 2019-07-02

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated drug study