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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and
Neulasta in healthy adult participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03251339
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03251339