Healthy SubjectsPhase 1B538-07NCT02237729
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
A Phase 1 study testing PF-06410293, Adalimumab-US and Adalimumab-EU in people with Healthy Subjects, run by Pfizer at 8 sites in United States.
Trial summary
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- PF-06410293, Adalimumab-US and Adalimumab-EU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2014to Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
De La Pedraja Radiology Associates
Coral Gables, Florida, 33134
SeaView Jacksonville
Jacksonville, Florida, 32256
SeaView Research, Inc.
Miami, Florida, 33126
SeaView Reseach Screening Office
Miami, Florida, 33134
SeaView Research, Inc. (Screening Office)
Miami, Florida, 33134
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66211
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
Prism Research, LLC
Saint Paul, Minnesota, 55114
About this study
Official title: Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
- Conditions
- Healthy Subjects
- Being tested
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Keywords
- healthy subjects, immunology, PK, Phase 1, bioequivalence, biosimilarity, adalimumab, single dose.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06410293Biological
Also called Adalimumab-Pfizer
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
Adalimumab-USBiological
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
Adalimumab-EUBiological
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
| Study group | Role | What they receive |
|---|---|---|
| PF-06410293 | Experimental | Not described Receives: Biological: PF-06410293 |
| Adalimumab-US | Active comparator | Not described Receives: Biological: Adalimumab-US |
| Adalimumab-EU | Active comparator | Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose Receives: Biological: Adalimumab-EU |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal serum concentration (Cmax)
maximal serum concentration (Cmax)
Measured: Day 1 - Day 50
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
Measured: 0-336 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
Measured: Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf)
AUC extrapolated to infinity (AUC0inf)
Measured: Day 1 - Day 50
Secondary outcomes (10)
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
Measured: Day 1- Day 71
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
Measured: Day 1- Day 71
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
Measured: Day 1 - Day 50
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US
Measured: 0-336 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US
Measured: Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
Measured: Day 1 - Day 50
time to reach the maximum concentration (Tmax)
time to reach the maximum concentration (Tmax)
Measured: Day 1 - Day 50
Apparent clearance (CL/F)
Apparent clearance (CL/F)
Measured: Day 1 - Day 50
Apparent volume of distribution (Vz/F)
Apparent volume of distribution (Vz/F)
Measured: Day 1 - Day 50
Terminal half-life (T1/2)
Terminal half-life (T1/2)
Measured: Day 1 - Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 362 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
- NCT02237729
- Sponsor's protocol ID
- B5381007
- Other IDs
- REFLECTIONS B538-07
- Acronym
- B538-07
- Status last verified
- Apr 2015
- First submitted
- 9 Sep 2014
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects
- ClinicalTrials.gov ID
- NCT02237729
- Acronym / sponsor ID
- B538-07 / B5381007
- Conditions
- Healthy Subjects
- Keywords
- healthy subjects, immunology, PK, Phase 1, bioequivalence, biosimilarity, adalimumab, single dose.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2014 (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 Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
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 |
|---|---|---|
| PF-06410293 | Experimental | Biological: PF-06410293 |
| Adalimumab-US | Active comparator | Biological: Adalimumab-US |
| Adalimumab-EU | Active comparator | Biological: Adalimumab-EUAdalimumab-EU will be administered as a single 40 mg, subcutaneous dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
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-06410293Also: Adalimumab-PfizerPF-06410293 will be administered as a single 40 mg, subcutaneous dose | Biological | PF-06410293 |
| Adalimumab-USAdalimumab-US will be administered as a single 40 mg, subcutaneous dose | Biological | Adalimumab-US |
| Adalimumab-EUAdalimumab-EU will be administered as a single 40 mg, subcutaneous dose | Biological | Adalimumab-EU |
Primary outcome
maximal serum concentration (Cmax)
Time frame: Day 1 - Day 50
maximal serum concentration (Cmax)
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
Time frame: 0-336 hours
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
Time frame: Day 1 - Day 50
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
AUC extrapolated to infinity (AUC0inf)
Time frame: Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf)
10 secondary outcomes
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
Time frame: Day 1- Day 71
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: Day 1- Day 71
maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
Time frame: Day 1 - Day 50
area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
Time frame: 0-336 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
Time frame: Day 1 - Day 50
AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
Time frame: Day 1 - Day 50
time to reach the maximum concentration (Tmax)
Time frame: Day 1 - Day 50
Apparent clearance (CL/F)
Time frame: Day 1 - Day 50
Apparent volume of distribution (Vz/F)
Time frame: Day 1 - Day 50
Terminal half-life (T1/2)
Time frame: Day 1 - Day 50
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 Apr 2015.
- 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
8 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 PF-06410293, Adalimumab-US and Adalimumab-EU in people with Healthy Subjects, run by Pfizer at 8 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 3 inclusion and 2 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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
maximal serum concentration (Cmax) (time frame: Day 1 - Day 50). The study lists 4 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 Apr 2015.