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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03251339




Registration number
NCT03251339
Ethics application status
Date submitted
15/08/2017
Date registered
16/08/2017
Date last updated
2/07/2019

Titles & IDs
Public title
Safety and Immunogenicity of MSB11455 in Healthy Participants
Scientific title
A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects
Secondary ID [1] 0 0
EMR200621-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MSB11455
Treatment: Drugs - US-Neulasta

Experimental: 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.

Experimental: 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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To Assess the Immunogenicity of MSB11455 Compared to Neulasta
Timepoint [1] 0 0
From first dose up to end of study (Up to 3 months)
Secondary outcome [1] 0 0
Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
Timepoint [1] 0 0
Day 1 up to a maximum of 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.
* Other protocol defined exclusion criteria could apply.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2018
Sample size
Target
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fresenius Kabi SwissBioSim GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radmila Kanceva, MD, PhD
Address 0 0
Fresenius Kabi SwissBioSim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03251339