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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/NCT03251248




Registration number
NCT03251248
Ethics application status
Date submitted
14/08/2017
Date registered
16/08/2017
Date last updated
2/07/2019

Titles & IDs
Public title
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
Scientific title
A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects
Secondary ID [1] 0 0
EMR200621-001
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 - Neulasta

Experimental: First MSB11455 Then Neulasta -

Experimental: First Neulasta Then MSB11455 -


Treatment: Drugs: MSB11455
Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.

Treatment: Drugs: Neulasta
Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta
Timepoint [1] 0 0
Pre-dose up to 15 days post-dose
Primary outcome [2] 0 0
Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta
Timepoint [2] 0 0
Pre-dose up to 15 days post-dose
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta
Timepoint [3] 0 0
Pre-dose up to 15 days post-dose
Primary outcome [4] 0 0
Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta
Timepoint [4] 0 0
Pre-dose up to 15 days post-dose
Primary outcome [5] 0 0
Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta
Timepoint [5] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [1] 0 0
Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta
Timepoint [1] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [2] 0 0
Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta
Timepoint [2] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [3] 0 0
Terminal rate constant (?z) of MSB11455 and Neulasta
Timepoint [3] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [4] 0 0
Terminal Half-life (t1/2) of MSB11455 and Neulasta
Timepoint [4] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [5] 0 0
Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta
Timepoint [5] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [6] 0 0
Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta
Timepoint [6] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [7] 0 0
Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta
Timepoint [7] 0 0
Pre-dose up to 15 days post-dose
Secondary outcome [8] 0 0
Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
Timepoint [8] 0 0
Day 1 up to a maximum of 15 months

Eligibility
Key inclusion criteria
- Subjects who provide signed and dated written informed consent

- 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
- Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455,
and laboratory test results within predefined ranges

- 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
Crossover
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
22/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2018
Sample size
Target
Accrual to date
Final
294
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment hospital [2] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
4006 - Herston

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of
MSB11455 and Neulasta in healthy adult subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03251248
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radmila Kanceva, MD, PhD
Address 0 0
Fresenius Kabi SwissBioSim GmbH
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