Clinical PharmacologyPhase 1NCT02629562
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects
A Phase 1 study testing B12019 and Neulasta in people with Clinical Pharmacology, run by Cinfa Biotech at 1 site in Germany.
Trial summary
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection. 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
- Clinical Pharmacology
- What is being tested?
- B12019 and Neulasta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Jul 2016
- 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
- Age ≥18 and ≤55 years
- BMI 22.0 - 28.0 kg/m2
- Non-smokers for at least 6 months prior to study start
- General good health, based on a comprehensive medical history and physical examination
- Adequate organ function and normal laboratory values (unless the investigator considers an abnormality to be clinically not relevant)
- Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) tests at screening
- Signed informed consent
Who cannot join
- Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
- Previous exposure to filgrastim or pegfilgrastim
- History of drug or alcohol abuse
- Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
- Medical history of haematological disease, including sickle cell disorders
- Recent infection (within 1 week prior to first dose)
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- Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
- Participation in an interventional or Phase I study in the last 3 months or is current a follow-up visit schedule for any study, or has participation in more than three studies of experimental drug products in the past 12 months prior to screening
- Subjects with ANC values outside the normal laboratory range at screening
- Use of prescription or over-the-counter drugs including vitamins within 4 weeks of first dosing
- Abnormalities in ECG
- Signs of dermatitis or skin abnormalities affecting the administration area and surroundings
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.
- Conditions
- Clinical Pharmacology
- Being tested
- B12019 and Neulasta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B12019 and NeulastaBiological
GCSF, Growth Colony Stimulating Factor
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | first dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously Receives: Biological: B12019 and Neulasta |
| Arm 2 | Experimental | first dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously Receives: Biological: B12019 and Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter AUC0-last
Area under the plasma concentration-time curve
Measured: 6 weeks
PK parameter Cmax
Maximum observed drug concentration
Measured: 6 weeks
PD parameter ANC
AUEC0-last
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 posted14 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies 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
- 172 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629562
- Sponsor's protocol ID
- B12019-101
- Status last verified
- Jul 2016
- First submitted
- 10 Dec 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02629562
- Acronym / sponsor ID
- B12019-101
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Cinfa BiotechIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- First posted
- 14 Dec 2015 (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.
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.
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 | Experimental | Biological: B12019 and Neulastafirst dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously |
| Arm 2 | Experimental | Biological: B12019 and Neulastafirst dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male subjects
- Age ≥18 and ≤55 years
- BMI 22.0 - 28.0 kg/m2
- Non-smokers for at least 6 months prior to study start
- General good health, based on a comprehensive medical history and physical examination
Key exclusion criteria (13 listed)
- Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
- Previous exposure to filgrastim or pegfilgrastim
- History of drug or alcohol abuse
- Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
- Medical history of haematological disease, including sickle cell disorders
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 |
|---|---|---|
| B12019 and NeulastaGCSF, Growth Colony Stimulating Factor | Biological | Arm 1, Arm 2 |
Primary outcome
PK parameter AUC0-last
Time frame: 6 weeks
Area under the plasma concentration-time curve
PK parameter Cmax
Time frame: 6 weeks
Maximum observed drug concentration
PD parameter ANC
Time frame: 6 weeks
AUEC0-last
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 13 Oct 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
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 B12019 and Neulasta in people with Clinical Pharmacology, 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 8 inclusion and 13 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 13 Oct 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?
PK parameter AUC0-last (time frame: 6 weeks). The study lists 3 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 13 Oct 2017.