HealthyPhase 1NCT03251248

Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

A Phase 1 study testing MSB11455 and Neulasta in people with Healthy, run by Fresenius Kabi SwissBioSim GmbH at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MSB11455 and Neulasta
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 294 participants
Where: 2 sitesAustralia
Study dates: 22 Aug 2017to 17 Oct 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who provide signed and dated written informed consent
Other protocol defined inclusion criteria could apply

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Q-Pharm Pty Ltd
Herston, 4006
Nucleus Network
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official 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

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.

Conditions: Healthy
Being tested: MSB11455, Neulasta
Keywords: MSB11455, Healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MSB11455Drug
Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.
NeulastaDrug
Also called pegfilgrastim
Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.

Study groups in NCT03251248
Study group	Role	What they receive
First MSB11455 Then Neulasta	Experimental	Not described Receives: Drug: MSB11455; Drug: Neulasta
First Neulasta Then MSB11455	Experimental	Not described Receives: Drug: MSB11455; Drug: Neulasta

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose

Secondary outcomes (8)

Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Terminal rate constant (λz) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Terminal Half-life (t1/2) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta
Measured: Pre-dose up to 15 days post-dose
Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs
Measured: Day 1 up to a maximum of 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201717 Oct 2018

First posted16 Aug 2017
Study start22 Aug 2017
Primary completion8 May 2018
Study completion17 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03251248
Sponsor's protocol ID: EMR200621-001
Status last verified: Jan 2019
First submitted: 14 Aug 2017
Last updated: 2 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lickliter J, Kanceva R, Vincent E, Schueler A, Harrison-Moench E, Yue CS, Stahl M, Ullmann M, Ghori V, Griffin P. Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial. Clin Ther. 2020 Aug;42(8):1508-1518.e1. doi: 10.1016/j.clinthera.2020.05.020. Epub 2020 Jul 11.
PubMed 32660769

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03251248
Acronym / sponsor ID: EMR200621-001
Conditions: Healthy
Keywords: MSB11455, Healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Fresenius Kabi SwissBioSim GmbHIndustry (pharma, biotech, devices)
Study start: 22 Aug 2017 (actual)
Primary completion: 8 May 2018 (actual)
Study completion: 17 Oct 2018 (actual)
First posted: 16 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
First MSB11455 Then Neulasta	Experimental	Drug: MSB11455, Drug: Neulasta
First Neulasta Then MSB11455	Experimental	Drug: MSB11455, Drug: Neulasta

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subjects who provide signed and dated written informed consent
Other protocol defined inclusion criteria could apply

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MSB11455Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.	Drug	First MSB11455 Then Neulasta, First Neulasta Then MSB11455
NeulastaAlso: pegfilgrastimSubjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.	Drug	First MSB11455 Then Neulasta, First Neulasta Then MSB11455

Primary outcome

Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose

8 secondary outcomes

Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Terminal rate constant (λz) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Terminal Half-life (t1/2) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta
Time frame: Pre-dose up to 15 days post-dose
Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
Time frame: Day 1 up to a maximum of 15 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Derived from this study: PubMed 32660769Lickliter J, Kanceva R, Vincent E, Schueler A, Harrison-Moench E, Yue CS, Stahl M, Ullmann M, Ghori V, Griffin P. Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial. Clin Ther. 2020 Aug;42(8):1508-1518.e1. doi: 10.1016/j.clinthera.2020.05.020. Epub 2020 Jul 11.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Radmila Kanceva, MD, PhD study director

Fresenius Kabi SwissBioSim GmbH

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MSB11455 and Neulasta in people with Healthy, run by Fresenius Kabi SwissBioSim GmbH at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta (time frame: Pre-dose up to 15 days post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03251248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.