HealthyPhase 1NCT02650973
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
A Phase 1 study testing CHS-1701 and Pegfilgrastim in people with Healthy, run by Coherus Oncology, Inc. at 4 sites in United States.
Trial summary
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CHS-1701 and Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2016to Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult male or female of ages 18 to 45 inclusive
- Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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
- Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder
- History of chronic or acute respiratory illness within the past 3 months
- 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
- History of known clinically significant drug and/or food allergies, including allergic reaction to latex
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medpace CPU
Cincinnati, Ohio, 45227
WCCT
Cypress, California, 90630
ICON
San Antonio, Texas
Spaulding
West Bend, Wisconsin, 53095
About this study
Official title: A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.
Read the detailed description
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period.
The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.
- Conditions
- Healthy
- Being tested
- CHS-1701, Pegfilgrastim
- Keywords
- Bioequivalence
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 |
|---|---|---|
| Sequence A | Experimental | 3 doses of CHS-1701 or Neulasta, random order Receives: Drug: CHS-1701; Drug: Pegfilgrastim |
| Sequence B | Experimental | 3 doses of CHS-1701 or Neulasta, random order Receives: Drug: CHS-1701; Drug: Pegfilgrastim |
| Sequence C | Experimental | 3 doses of CHS-1701 or Neulasta, random order Receives: Drug: CHS-1701; Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence as measured by PK and PD
The primary objective of this study is to assess the bioequivalence 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 (5)
PK Profile: Cmax
Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax)
Measured: 84 Days
PK Profile: tmax
Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax)
Measured: 84 Days
PK Profile: AUC0-t
Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t)
Measured: 84 Days
PK Profile: t1/2
Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (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 posted8 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 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 BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650973
- Sponsor's protocol ID
- CHS-1701-05
- Status last verified
- Jul 2016
- First submitted
- 5 Jan 2016
- Last updated
- 1 Aug 2016
- 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 35034311Finck B, Tang H, Civoli F, Hodge J, O'Kelly H, Vexler V. Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects. Adv Ther. 2020 Oct;37(10):4291-4307. doi: 10.1007/s12325-020-01459-y. Epub 2020 Aug 13.
PubMed 32789809
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02650973
- Acronym / sponsor ID
- CHS-1701-05
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jan 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.
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.
Detailed description
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period.
The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: CHS-1701, Drug: Pegfilgrastim3 doses of CHS-1701 or Neulasta, random order |
| Sequence B | Experimental | Drug: CHS-1701, Drug: Pegfilgrastim3 doses of CHS-1701 or Neulasta, random order |
| Sequence C | Experimental | Drug: CHS-1701, Drug: Pegfilgrastim3 doses of CHS-1701 or Neulasta, random order |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult male or female of ages 18 to 45 inclusive
- Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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 (7 listed)
- Previous exposure to pegfilgrastim or filgrastim
- Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder
- History of chronic or acute respiratory illness within the past 3 months
- 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
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 | Sequence A, Sequence B, Sequence C |
| PegfilgrastimAlso: Neulasta | Drug | Sequence A, Sequence B, Sequence C |
Primary outcome
Bioequivalence as measured by PK and PD
Time frame: 84 Days
The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)
5 secondary outcomes
PK Profile: Cmax
Time frame: 84 Days
PK Profile: tmax
Time frame: 84 Days
PK Profile: AUC0-t
Time frame: 84 Days
PK Profile: 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 1 Aug 2016.
- 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.
- Derived from this study: PubMed 32789809Finck B, Tang H, Civoli F, Hodge J, O'Kelly H, Vexler V. Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects. Adv Ther. 2020 Oct;37(10):4291-4307. doi: 10.1007/s12325-020-01459-y. Epub 2020 Aug 13.
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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 BioSciences
4 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 CHS-1701 and Pegfilgrastim in people with Healthy, run by Coherus Oncology, Inc. at 4 sites 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 7 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Bioequivalence as measured by PK and PD (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 NCT02650973, which also lists 2 linked publications.
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 1 Aug 2016.