Healthy VolunteersPhase 1NCT02912377
Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects
A Phase 1 study testing Neulasta, B12019 in people with Healthy Volunteers, run by Cinfa Biotech at 1 site in Germany.
Trial summary
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Neulasta, B12019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to May 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, between 18 and 55 years of age (inclusive).
- BMI between 20.0 and 30.0 kg/m² (inclusive).
- Weight between 60 and 100 kg (inclusive).
- Non-smoker for at least 3 months or mild smokers with a consumption of less than 5 cigarettes (or equivalent) per day prior to study start.
- Healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing.
- Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol and to participate in the entire trial period.
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- Subjects who are able and willing to give written informed consent.
- Male subject and his female spouse/partner who is of childbearing potential must be using effective contraception starting at screening and continue throughout the clinical study period.
- Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.
Who cannot join
- History of:
- Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, central nervous system diseases or other significant acute or chronic diseases, especially hereditary fructose intolerance, which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation.
- Subjects with clinically relevant neurologic or psychiatric illness.
- Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing).
- Previous exposure to pegfilgrastim.
- Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta® as listed in section 7.2.
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- History of allergy to any recombinant protein.
- History of cancer.
- History of haematological disease, including sickle cell disorder.
- History of pulmonary infiltrates or pneumonia within 6 months before the first study drug administration.
- Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics, etc.).
- Subjects not willing or able to comply with the food and beverage restrictions (grapefruit/pomelo, starfruit, poppy seeds).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects
- Conditions
- Healthy Volunteers
- Being tested
- Neulasta, B12019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neulasta, B12019Biological
GCSF, Growth Colony Stimulating Factor
| Study group | Role | What they receive |
|---|---|---|
| Arm 1; B12019 / Neulasta | Experimental | 2 single doses of B12019 followed by one dose of Neulasta Receives: Biological: Neulasta, B12019 |
| Arm 2; Neulasta / B12019 | Experimental | 2 single doses of Neulasta followed by one dose B12019 Receives: Biological: Neulasta, B12019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anti-drug antibodies (ADAs)
Incidence of anti-drug antibodies over time (ADAs)
Measured: 6 weeks
Absolute Neutrophil count (ANC)
AUEC0-last of ANC
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinfa Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lissy, MD, Principal investigator, Nuvisan GmbH, 89231 Neu-Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912377
- Sponsor's protocol ID
- B12019-102
- Status last verified
- May 2017
- First submitted
- 19 Sep 2016
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02912377
- Acronym / sponsor ID
- B12019-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cinfa BiotechIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1; B12019 / Neulasta | Experimental | Biological: Neulasta, B120192 single doses of B12019 followed by one dose of Neulasta |
| Arm 2; Neulasta / B12019 | Experimental | Biological: Neulasta, B120192 single doses of Neulasta followed by one dose B12019 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subjects, between 18 and 55 years of age (inclusive).
- BMI between 20.0 and 30.0 kg/m² (inclusive).
- Weight between 60 and 100 kg (inclusive).
- Non-smoker for at least 3 months or mild smokers with a consumption of less than 5 cigarettes (or equivalent) per day prior to study start.
- Healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing.
Key exclusion criteria (12 listed)
- Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, central nervous system diseases or other significant acute or chronic diseases, especially hereditary fructose intolerance, which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation.
- Subjects with clinically relevant neurologic or psychiatric illness.
- Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing).
- Previous exposure to pegfilgrastim.
- Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta® as listed in section 7.2.
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 |
|---|---|---|
| Neulasta, B12019GCSF, Growth Colony Stimulating Factor | Biological | Arm 1; B12019 / Neulasta, Arm 2; Neulasta / B12019 |
Primary outcome
Incidence of anti-drug antibodies (ADAs)
Time frame: 6 weeks
Incidence of anti-drug antibodies over time (ADAs)
Absolute Neutrophil count (ANC)
Time frame: 6 weeks
AUEC0-last of ANC
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 18 May 2017.
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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.
Michael Lissy, MD principal investigator
Nuvisan GmbH, 89231 Neu-Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neulasta, B12019 in people with Healthy Volunteers, run by Cinfa Biotech at 1 site in Germany.
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 9 inclusion and 12 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Incidence of anti-drug antibodies (ADAs) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2017.