Safety and Immunogenicity of MSB11455 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MSB11455; Drug: US-Neulasta

• Registration Number: NCT03251339
• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Study Start: 2017-08-21
• Primary Completion: 2018-02-05
• Study Completion: 2018-09-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSB11455	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.
US-Neulasta	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.

Primary Outcome Measures

Name	Time	Method
To Assess the Immunogenicity of MSB11455 Compared to Neulasta	From first dose up to end of study (Up to 3 months)	Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)

Secondary Outcome Measures

Name	Time	Method
Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)	Day 1 up to a maximum of 1 year	Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs

Trial Locations

Locations (2)

Christchurch Clinical Studies Trust; 🇳🇿 Christchurch, New Zealand

Auckland Clinical Studies Ltd; 🇳🇿 Auckland, New Zealand