Immunity, HumoralPhase 1NCT02418104
Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®
A Phase 1 study testing CHS-1701 and Pegfilgrastim (Neulasta) in people with Immunity, Humoral, run by Coherus Oncology, Inc. at 4 sites in United States.
Trial summary
This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections 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
- Immunity, Humoral
- What is being tested?
- CHS-1701 and Pegfilgrastim (Neulasta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to Dec 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
4 sites in 1 country.
United States4 sites
Medpace
Cincinnati, Ohio
Vince & Associates Clinical Research
Overland Park, Kansas
ICON
San Antonio, Texas
Spaulding Clinical
West Bend, Wisconsin
About this study
Official title: A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta® in Healthy Subjects
This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.
- Conditions
- Immunity, Humoral
- Being tested
- CHS-1701, Pegfilgrastim (Neulasta)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS-1701Drug
Pegfilgrastim (Neulasta)Drug
Also called Neulasta
| Study group | Role | What they receive |
|---|---|---|
| CHS-1701 | Experimental | CHS-1701 followed by CHS-1701 Receives: Drug: CHS-1701 |
| Neulasta | Active comparator | Neulasta followed by Neulasta Receives: Drug: Pegfilgrastim (Neulasta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the immunogenicity of CHS-1701 compared to Neulasta
The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response
Measured: 84 days
Secondary outcomes (3)
Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t)
Measured: 84 days
Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)
Measured: 84 days
Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, 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 posted16 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 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 Immunity, HumoralStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 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
- NCT02418104
- Sponsor's protocol ID
- CHS-1701-04
- Status last verified
- Jan 2016
- First submitted
- 8 Apr 2015
- Last updated
- 7 Jan 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 35034311
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02418104
- Acronym / sponsor ID
- CHS-1701-04
- Conditions
- Immunity, Humoral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Apr 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, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHS-1701 | Experimental | Drug: CHS-1701CHS-1701 followed by CHS-1701 |
| Neulasta | Active comparator | Drug: Pegfilgrastim (Neulasta)Neulasta followed by Neulasta |
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 |
| Pegfilgrastim (Neulasta)Also: Neulasta | Drug | Neulasta |
Primary outcome
To assess the immunogenicity of CHS-1701 compared to Neulasta
Time frame: 84 days
The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response
3 secondary outcomes
Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t)
Time frame: 84 days
Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)
Time frame: 84 days
Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, 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 7 Jan 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.
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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.
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 (Neulasta) in people with Immunity, Humoral, 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 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 7 Jan 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?
To assess the immunogenicity of CHS-1701 compared to Neulasta (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 NCT02418104, 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 7 Jan 2016.