HealthyPhase 1NCT03599063
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
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 subjects following single ascending doses This is the first clinical study of PF-06946860. 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
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 18 Sep 2019
- 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
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF 06946860 TO HEALTHY ADULT SUBJECTS
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult subjects following single ascending doses This is the first clinical study of PF-06946860.
- 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 |
|---|---|---|
| Cohort 1 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 2 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 3 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 4 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 5 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 6 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Cohort 7 | Experimental | Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo Receives: Biological: PF-06946860; Other: Placebo |
| Optional: Cohort 8 | Experimental | Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects Receives: Biological: PF-06946860; 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 9 weeks post dose
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
Measured: Baseline, up to 9 weeks post dose, as data permit
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: Baseline, up to 9 weeks post dose, as data permit
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Baseline, up to 9 weeks post dose, as data permit
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Baseline, up to 9 weeks post dose, as data permit
Incidence of development of ADA, and if necessary NAb, against PF-06946860
Measured: Baseline, up to 9 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 posted26 Jul 2018
- Study start30 Jul 2018
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 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
- NCT03599063
- Sponsor's protocol ID
- C3651001
- Other IDs
- FIH
- Status last verified
- Nov 2019
- First submitted
- 17 Jul 2018
- Last updated
- 8 Nov 2019
- 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 8 Nov 2019. 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, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF 06946860 TO HEALTHY ADULT SUBJECTS
- ClinicalTrials.gov ID
- NCT03599063
- Acronym / sponsor ID
- C3651001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 26 Jul 2018 (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 subjects following single ascending doses This is the first clinical study of PF-06946860.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo |
| Cohort 2 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo |
| Cohort 3 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo |
| Cohort 4 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo |
| Cohort 5 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo |
| Cohort 6 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo |
| Cohort 7 | Experimental | Biological: PF-06946860, Other: PlaceboSingle subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo |
| Optional: Cohort 8 | Experimental | Biological: PF-06946860, Other: PlaceboOptional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects |
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 | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Optional: Cohort 8 |
| PlaceboPlacebo, administered subcutaneously | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Optional: Cohort 8 |
Primary outcome
Incidence of participants experiencing AE.
Time frame: Up 9 weeks post dose
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline, up to 9 weeks post dose, as data permit
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Baseline, up to 9 weeks post dose, as data permit
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Baseline, up to 9 weeks post dose, as data permit
Plasma Decay Half-Life (t1/2)
Time frame: Baseline, up to 9 weeks post dose, as data permit
Incidence of development of ADA, and if necessary NAb, against PF-06946860
Time frame: Baseline, up to 9 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 8 Nov 2019.
- 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 8 Nov 2019. 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?
Incidence of participants experiencing AE. (time frame: Up 9 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 8 Nov 2019.