HealthyPhase 1NCT01870986
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
A Phase 1 study testing PF-06410293, Humira (adalimumab-EU) and Humira (adalimumab-US) in people with Healthy, run by Pfizer at 2 sites in 2 countries.
Trial summary
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). 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-06410293, Humira (adalimumab-EU) and Humira (adalimumab-US)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2013to Feb 2014
- 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 male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
Who cannot join
- Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
- Conditions
- Healthy
- Being tested
- PF-06410293, Humira (adalimumab-EU), Humira (adalimumab-US)
- Keywords
- Healthy Volunteers, Phase 1, PK, adalimumab, Single-dose, Immunology, Bioequivalence, Biosimilarity, Similarity.
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
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Humira (adalimumab-EU)Biological
Also called adalimumab (European Union)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Humira (adalimumab-US)Biological
Also called adalimumab (United States)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | PF-06410293 Receives: Biological: PF-06410293 |
| B | Active comparator | Adalimumab-EU Receives: Biological: Humira (adalimumab-EU) |
| C | Active comparator | Adalimumab-US Receives: Biological: Humira (adalimumab-US) |
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 43
Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
Measured: Day 1 - Day 43
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
Measured: Day 1 - Day 43
Secondary outcomes (5)
Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)
Measured: Day 1 - Day 71
Time to Reach Maximum Observed Serum Concentration (Tmax)
Measured: Day 1- Day 43
Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing
Measured: Day 1- Day 43
Systemic Clearance (CL)
Measured: Day 1- Day 43
Serum Decay Half-Life (t1/2)
Serum decay half-life is teh time for the serum concentration to decrease by one half
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 posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 210 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
- NCT01870986
- Sponsor's protocol ID
- B5381001
- Other IDs
- REFLECTIONS B538-01
- Status last verified
- Feb 2014
- First submitted
- 3 Jun 2013
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 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-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
- ClinicalTrials.gov ID
- NCT01870986
- Acronym / sponsor ID
- B5381001
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Phase 1, PK, adalimumab, Single-dose, Immunology, Bioequivalence, Biosimilarity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Jun 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.
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
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 | Experimental | Biological: PF-06410293PF-06410293 |
| B | Active comparator | Biological: Humira (adalimumab-EU)Adalimumab-EU |
| C | Active comparator | Biological: Humira (adalimumab-US)Adalimumab-US |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
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-Pfizer40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. | Biological | A |
| Humira (adalimumab-EU)Also: adalimumab (European Union)40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. | Biological | B |
| Humira (adalimumab-US)Also: adalimumab (United States)40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. | Biological | C |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 - Day 43
Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)
Time frame: Day 1 - Day 43
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)
Time frame: Day 1 - Day 43
5 secondary outcomes
Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)
Time frame: Day 1 - Day 71
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1- Day 43
Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing
Time frame: Day 1- Day 43
Systemic Clearance (CL)
Time frame: Day 1- Day 43
Serum Decay 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 14 Feb 2014.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06410293, Humira (adalimumab-EU) and Humira (adalimumab-US) in people with Healthy, run by Pfizer at 2 sites in 2 countries.
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 1 inclusion and 1 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Belgium. 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 43). 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?
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 14 Feb 2014.