Healthy SubjectsPhase 1B538-05NCT02572245
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
A Phase 1 study testing PF-06410293 PFS and PF-06410293 PFP in people with Healthy Subjects, run by Pfizer at 1 site in United States.
Trial summary
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- PF-06410293 PFS and PF-06410293 PFP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or 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.
- Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.
- All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
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).
- Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
- Conditions
- Healthy Subjects
- Being tested
- PF-06410293 PFS, PF-06410293 PFP
- Keywords
- Healthy Subjects, Device, PK, Phase 1, Bioequivalence, Adalimumab, Single Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06410293 PFSDevice
PF-06410293 40 mg administered subcutaneously by Prefilled syringe
PF-06410293 PFPDevice
PF-06410293 40 mg administered subcutaneously by prefilled pen
| Study group | Role | What they receive |
|---|---|---|
| PF-06410293 PFS (Prefilled Syringe) | Active comparator | PF-06410293 40 mg administered by Prefilled Syringe (PFS) Receives: Device: PF-06410293 PFS |
| PF-06410293 PFP (Prefilled Pen) | Active comparator | PF-06410293 40 mg administered by Prefilled pen Receives: Device: PF-06410293 PFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (Cmax)
Measured: Day 1 - Day 15
Area under the concentration curve (AUC 0-2wk)
Measured: Day 1-Day 15
Secondary outcomes (8)
Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose
Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device
Measured: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose
Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device
Measured: 1, 3, 8, 12 and 24 hours post injection
Time to reach the maximum serum concentration (Tmax)
Measured: Day 1 - Day 43
AUC from time 0 to the last time point with quantifiable concentration (AUCT)
Measured: Day 1 - Day 43
AUC extrapolated to infinity (AUC0 inf)
Measured: Day 1 - Day 43
Volume of distribution (Vz/F),
Measured: Day 1 - Day 43
Apparent clearance (CL/F)
Measured: Day 1 - Day 43
Terminal half life (t1/2)
Measured: Day 1 - Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
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 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
- None (open label)
- Enrolment
- 164 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
- NCT02572245
- Sponsor's protocol ID
- B5381005
- Acronym
- B538-05
- Status last verified
- Jun 2016
- First submitted
- 25 Sep 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox DS, Alvarez DF, Bock AE, Cronenberger CL. Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 2021 Mar 25.
PubMed 33765358
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02572245
- Acronym / sponsor ID
- B538-05 / B5381005
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects, Device, PK, Phase 1, Bioequivalence, Adalimumab, Single Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Oct 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 study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06410293 PFS (Prefilled Syringe) | Active comparator | Device: PF-06410293 PFSPF-06410293 40 mg administered by Prefilled Syringe (PFS) |
| PF-06410293 PFP (Prefilled Pen) | Active comparator | Device: PF-06410293 PFPPF-06410293 40 mg administered by Prefilled pen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
- Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or 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.
- Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.
- All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
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).
- Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- 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-06410293 PFSPF-06410293 40 mg administered subcutaneously by Prefilled syringe | Device | PF-06410293 PFS (Prefilled Syringe) |
| PF-06410293 PFPPF-06410293 40 mg administered subcutaneously by prefilled pen | Device | PF-06410293 PFP (Prefilled Pen) |
Primary outcome
Maximum serum concentration (Cmax)
Time frame: Day 1 - Day 15
Area under the concentration curve (AUC 0-2wk)
Time frame: Day 1-Day 15
8 secondary outcomes
Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose
Time frame: Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose
Time frame: 1, 3, 8, 12 and 24 hours post injection
Time to reach the maximum serum concentration (Tmax)
Time frame: Day 1 - Day 43
AUC from time 0 to the last time point with quantifiable concentration (AUCT)
Time frame: Day 1 - Day 43
AUC extrapolated to infinity (AUC0 inf)
Time frame: Day 1 - Day 43
Volume of distribution (Vz/F),
Time frame: Day 1 - Day 43
Apparent clearance (CL/F)
Time frame: Day 1 - Day 43
Terminal half life (t1/2)
Time frame: Day 1 - Day 43
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 6 Jun 2016.
- Derived from this study: PubMed 33765358Cox DS, Alvarez DF, Bock AE, Cronenberger CL. Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 2021 Mar 25.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Healthy Participants
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-06410293 PFS and PF-06410293 PFP in people with Healthy Subjects, 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 5 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 6 Jun 2016. 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 serum concentration (Cmax) (time frame: Day 1 - Day 15). The study lists 2 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 NCT02572245, 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 6 Jun 2016.