HealthyPhase 1NCT01844804
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
A Phase 1 study testing PF-06438179 and Remicade in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06438179 and Remicade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Previous exposure to a monoclonal antibody, or current use of other biologics.
- History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
- History of tuberculosis (TB) or a positive latent TB test at Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
- Conditions
- Healthy
- Being tested
- PF-06438179, Remicade
- Keywords
- Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Infliximab, Healthy Volunteers, Single-dose, Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06438179Biological
Also called Infliximab-Pfizer
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
RemicadeBiological
Also called Infliximab (European Union)
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
RemicadeBiological
Also called Infliximab (United States)
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
| Study group | Role | What they receive |
|---|---|---|
| A = PF-06438179 | Experimental | Not described Receives: Biological: PF-06438179 |
| B = Infliximab-EU | Active comparator | Not described Receives: Biological: Remicade |
| C = Infliximab-US | Active comparator | Not described Receives: Biological: Remicade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Measured: Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Measured: Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Measured: Day 1 - Day 57
Secondary outcomes (4)
Systemic Clearance (CL)
Measured: Day 1 - Day 57
Terminal Disposition Half-Life (t1/2)
Measured: Day 1 - Day 57
Volume of Distribution at Steady State (Vss)
Measured: Day 1 - Day 57
Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)
Measured: Day 1 - LSLV or Day 85 whichever occurs later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
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 HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844804
- Sponsor's protocol ID
- B5371001
- Other IDs
- REFLECTIONS B537-01
- Status last verified
- Jan 2014
- First submitted
- 29 Apr 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.
PubMed 29504427
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01844804
- Acronym / sponsor ID
- B5371001
- Conditions
- Healthy
- Keywords
- Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Infliximab, Healthy Volunteers, Single-dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 May 2013 (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.
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A = PF-06438179 | Experimental | Biological: PF-06438179 |
| B = Infliximab-EU | Active comparator | Biological: Remicade |
| C = Infliximab-US | Active comparator | Biological: Remicade |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs).
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Previous exposure to a monoclonal antibody, or current use of other biologics.
- History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
- History of tuberculosis (TB) or a positive latent TB test at Screening.
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 |
|---|---|---|
| PF-06438179Also: Infliximab-PfizerSingle-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 | Biological | A = PF-06438179 |
| RemicadeAlso: Infliximab (European Union)Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 | Biological | B = Infliximab-EU |
| RemicadeAlso: Infliximab (United States)Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1 | Biological | C = Infliximab-US |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Time frame: Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Time frame: Day 1 - Day 57
4 secondary outcomes
Systemic Clearance (CL)
Time frame: Day 1 - Day 57
Terminal Disposition Half-Life (t1/2)
Time frame: Day 1 - Day 57
Volume of Distribution at Steady State (Vss)
Time frame: Day 1 - Day 57
Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)
Time frame: Day 1 - LSLV or Day 85 whichever occurs later
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 2014.
- Derived from this study: PubMed 29504427Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-06438179 and Remicade in people with Healthy, run by Pfizer 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 2 inclusion and 4 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 2014. 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?
Maximum Observed Serum Concentration (Cmax) (time frame: Day 1 - Day 57). 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?
On the ClinicalTrials.gov record for NCT01844804, 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 2014.