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
1 other identifier
interventional
336
1 country
2
Brief Summary
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2017
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2018
CompletedJuly 2, 2019
March 1, 2019
6 months
August 15, 2017
June 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Assess the Immunogenicity of MSB11455 Compared to Neulasta
Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)
From first dose up to end of study (Up to 3 months)
Secondary Outcomes (1)
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
Study Arms (2)
MSB11455
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Participants who provide signed and dated written informed consent.
- Participants with laboratory test results within predefined ranges.
You may not qualify if:
- Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Auckland Clinical Studies Ltd
Auckland, 1150, New Zealand
Christchurch Clinical Studies Trust
Christchurch, 8001, New Zealand
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Radmila Kanceva, MD, PhD
Fresenius Kabi SwissBioSim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 16, 2017
Study Start
August 21, 2017
Primary Completion
February 5, 2018
Study Completion
September 22, 2018
Last Updated
July 2, 2019
Record last verified: 2019-03