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Trial details imported from ClinicalTrials.gov

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

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/NCT03251248