BioequivalencePhase 1NCT02385851
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)
A Phase 1 study testing CHS-1701 and Pegfilgrastim in people with Bioequivalence, run by Coherus Oncology, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- CHS-1701 and Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult male or female of ages 18 to 50 inclusive
- Body weight > 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
- Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
- Negative urine pregnancy test in women of childbearing potential
Who cannot join
- Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
- Chemistry and hematology values outside protocol specified range
- Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
- History of chronic or acute respiratory illness within the past 4 weeks
- Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
- No prescription or nonprescription drugs during the study
- Participation in an investigational clinical study within 30 days prior to screening
- Known or suspected allergic reaction to latex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
Read the detailed description
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.
The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.
- Conditions
- Bioequivalence
- Being tested
- CHS-1701, Pegfilgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS-1701Drug
PegfilgrastimDrug
Also called Neulasta
| Study group | Role | What they receive |
|---|---|---|
| CHS-1701/Neulasta | Experimental | CHS-1701 followed by Neulasta (crossover) Receives: Drug: CHS-1701; Drug: Pegfilgrastim |
| Neulasta/CHS-1701 | Experimental | Neulasta followed by CHS-1701 (crossover) Receives: Drug: CHS-1701; Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biosimilarity as measured by absolute neutrophil count (ANC)
The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).
Measured: 84 Days
Secondary outcomes (2)
PK Profile: Cmax (tmax), AUC0-t, and t1/2
Characterization of the PK profile of CHS-1701 using standard parameters (Cmax (tmax), AUC0-t, and t1/2)
Measured: 84 Days
Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).
Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
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 BioequivalenceStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherus Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Finck, MD, Study director, Coherus Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385851
- Sponsor's protocol ID
- CHS-1701-03
- Status last verified
- Aug 2015
- First submitted
- 2 Mar 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16.
PubMed 35034311
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. 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 Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02385851
- Acronym / sponsor ID
- CHS-1701-03
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Mar 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.
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
Detailed description
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.
The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHS-1701/Neulasta | Experimental | Drug: CHS-1701, Drug: PegfilgrastimCHS-1701 followed by Neulasta (crossover) |
| Neulasta/CHS-1701 | Experimental | Drug: CHS-1701, Drug: PegfilgrastimNeulasta followed by CHS-1701 (crossover) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult male or female of ages 18 to 50 inclusive
- Body weight > 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
- Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
- Negative urine pregnancy test in women of childbearing potential
Key exclusion criteria (8 listed)
- Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
- Chemistry and hematology values outside protocol specified range
- Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
- History of chronic or acute respiratory illness within the past 4 weeks
- Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
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 |
|---|---|---|
| CHS-1701 | Drug | CHS-1701/Neulasta, Neulasta/CHS-1701 |
| PegfilgrastimAlso: Neulasta | Drug | CHS-1701/Neulasta, Neulasta/CHS-1701 |
Primary outcome
Biosimilarity as measured by absolute neutrophil count (ANC)
Time frame: 84 Days
The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).
2 secondary outcomes
PK Profile: Cmax (tmax), AUC0-t, and t1/2
Time frame: 84 Days
Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).
Time frame: 84 Days
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 Aug 2015.
- Derived from this study: PubMed 35034311Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16.
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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.
Barbara Finck, MD study director
Coherus Oncology, Inc.
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 CHS-1701 and Pegfilgrastim in people with Bioequivalence, run by Coherus Oncology, Inc. at 1 site in United States.
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 4 inclusion and 8 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 Aug 2015. 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 United States. 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?
Biosimilarity as measured by absolute neutrophil count (ANC) (time frame: 84 Days). 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 NCT02385851, 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 13 Aug 2015.