HealthyPhase 1NCT03974776
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants
A Phase 1 study testing PF-06946860 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration. 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-06946860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 10 Jan 2020
- 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 nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- History of allergic reactions to diagnostic or therapeutic protein or human albumin.
- History of recurrent infections or active infection within 28 days of screening.
- Exposure to live vaccines within 28 days of screening.
- History of regular alcohol consumption or positive drug test
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials LLC-Clinical Research
Anaheim, California, 92801
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF-06946860 TO HEALTHY ADULT JAPANESE PARTICIPANTS
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.
- Conditions
- Healthy
- Being tested
- PF-06946860, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06946860Biological
PF-06946860 administered subcutaneously
PlaceboOther
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| PF-06946860 | Experimental | Single subcutaneous administration of PF-06946860 Receives: Biological: PF-06946860 |
| Placebo | Placebo comparator | Single subcutaneous administration of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants experiencing AE
Measured: Up to 20 weeks post-dose
Secondary outcomes (5)
Maximum Observed PF-06946860 Concentration (Cmax)
Measured: Up to 20 weeks post-dose
Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast)
Measured: Up to 20 weeks post-dose
Time to Reach Maximum Observed PF-06946860 Concentration (Tmax)
Measured: Up to 20 weeks post-dose
PF-06946860 Half-Life (t1/2)
Time measured for the PF-06946860 concentration to decrease by one half.
Measured: Up to 20 weeks post-dose, as data permit
Incidence of development of ADA, and if necessary NAb, against PF-06946860
Measured: Up to 20 weeks post-dose, as data permit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start8 Jul 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
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
- 8 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
- NCT03974776
- Sponsor's protocol ID
- C3651002
- Other IDs
- FIP, Japanese Ph1
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF-06946860 TO HEALTHY ADULT JAPANESE PARTICIPANTS
- ClinicalTrials.gov ID
- NCT03974776
- Acronym / sponsor ID
- C3651002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06946860 | Experimental | Biological: PF-06946860Single subcutaneous administration of PF-06946860 |
| Placebo | Placebo comparator | Other: PlaceboSingle subcutaneous administration of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.
Key exclusion criteria (8 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- History of allergic reactions to diagnostic or therapeutic protein or human albumin.
- History of recurrent infections or active infection within 28 days of screening.
- Exposure to live vaccines within 28 days of screening.
- History of regular alcohol consumption or positive drug test
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-06946860PF-06946860 administered subcutaneously | Biological | PF-06946860 |
| PlaceboPlacebo administered subcutaneously | Other | Placebo |
Primary outcome
Incidence of participants experiencing AE
Time frame: Up to 20 weeks post-dose
5 secondary outcomes
Maximum Observed PF-06946860 Concentration (Cmax)
Time frame: Up to 20 weeks post-dose
Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast)
Time frame: Up to 20 weeks post-dose
Time to Reach Maximum Observed PF-06946860 Concentration (Tmax)
Time frame: Up to 20 weeks post-dose
PF-06946860 Half-Life (t1/2)
Time frame: Up to 20 weeks post-dose, as data permit
Incidence of development of ADA, and if necessary NAb, against PF-06946860
Time frame: Up to 20 weeks post-dose, as data permit
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 29 Jan 2020.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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-06946860 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 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 29 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Incidence of participants experiencing AE (time frame: Up to 20 weeks post-dose). 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 29 Jan 2020.