HealthyPhase 1NCT02531815
Dose Escalation Study of PF-06741086 In Healthy Subjects
A Phase 1 study testing PF-06741086 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06741086
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2015to Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).
Who cannot join
- Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
- Use of nicotine/tobacco products
- Clotting disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects
This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
- Conditions
- Healthy
- Being tested
- PF-06741086, Placebo
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics, Phase 1, first in human, monoclonal antibody, tissue factor pathway inhibitor, japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06741086Biological
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
PlaceboDrug
Also called saline placebo
Placebo for PF-06741086, single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 2 (SC) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 3 (SC) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 4 (Intravenous [IV]) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 5 (IV) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 6 (IV) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 7 (IV) PF-06741086, Placebo | Experimental | Not described Receives: Biological: PF-06741086; Drug: Placebo |
| Cohort 8 (subcutaneous [SC]) PF-06741086 | Experimental | Not described Receives: Biological: PF-06741086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Measured: Day 1 up to Day 84
Percentage of subjects with laboratory abnormalities
Measured: Day 1 up to Day 84
Number of subjects with change from baseline in vital signs
blood pressure, pulse rate, temperature, respiration rate
Measured: Day 1 up to Day 84
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Measured: Day 1 to Day 84
Percentage of subjects with changes from baseline in physical examination
Measured: Day 1 to Day 84
Percentage of subjects with infusion site reactions
Measured: Day 1 up to Day 7
Percentage of subjects with injection site reactions
Measured: Day 1 to Day 7
Secondary outcomes (18)
Plasma PF-06741086 concentrations
Measured: Day 1 up to Day 84
Maximum observed plasma concentration (Cmax)
Measured: Day 1 up to Day 84
Time for Cmax (Tmax)
Measured: Day 1 up to Day 84
Area under the curve from time zero to last quantifiable concentration (AUClast)
Measured: Day 1 up to Day 84
Terminal half-life (t 1/2)
Measured: Day 1 up to Day 84
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Measured: Day 1 up to Day 84
Volume of distribution at steady state (Vss)
Intravenous administration only
Measured: Day 1 up to Day 84
Apparent volume of distribution (Vz/F)
Subcutaneous administration only
Measured: Day 1 up to Day 84
Clearance (CL)
Intravenous administration only
Measured: Day 1 up to Day 84
Apparent clearance (CL/F)
Subcutaneous administration only
Measured: Day 1 up to Day 84
Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)]
Measured: Day 1 up to Day 84
Mean residence time (MRT)
Measured: Day 1 up to Day 84
Total tissue factor pathway inhibitor concentrations over time
Measured: Day 1 up to Day 84
Thrombin generation
may include lag time, peak thrombin generation, and endogenous thrombin generation potential
Measured: Day 1 up to Day 84
Prothrombin fragment 1+2 (PF1+2) concentrations over time
Measured: Day 1 up to Day 84
D-dimer concentrations over time
Measured: Day 1 up to Day 84
Dilute prothrombin time (dPT)
Measured: Day 1 up to Day 84
Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production
Immunogenicity
Measured: Day 1 up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 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 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 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
- NCT02531815
- Sponsor's protocol ID
- B7841001
- Other IDs
- 2015-001821-17, 2015
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nayak S, Suzuki A, Ravva P, Raje S. Clinical Pharmacokinetics and Pharmacodynamics of Marstacimab, an Anti-tissue Factor Pathway Inhibitor Monoclonal Antibody, in Adolescent and Adult Participants with Hemophilia. Clin Pharmacokinet. 2026 Sep 4. doi: 10.1007/s40262-026-01695-5. Online ahead of print.
PubMed 42698050
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02531815
- Acronym / sponsor ID
- B7841001
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics, Phase 1, first in human, monoclonal antibody, tissue factor pathway inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Aug 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 Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 2 (SC) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 3 (SC) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 4 (Intravenous [IV]) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 5 (IV) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 6 (IV) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 7 (IV) PF-06741086, Placebo | Experimental | Biological: PF-06741086, Drug: Placebo |
| Cohort 8 (subcutaneous [SC]) PF-06741086 | Experimental | Biological: PF-06741086 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).
Key exclusion criteria (3 listed)
- Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
- Use of nicotine/tobacco products
- Clotting disorders
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-06741086PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s) | Biological | Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo, Cohort 2 (SC) PF-06741086, Placebo, Cohort 3 (SC) PF-06741086, Placebo, Cohort 4 (Intravenous [IV]) PF-06741086, Placebo, Cohort 5 (IV) PF-06741086, Placebo, Cohort 6 (IV) PF-06741086, Placebo, Cohort 7 (IV) PF-06741086, Placebo, Cohort 8 (subcutaneous [SC]) PF-06741086 |
| PlaceboAlso: saline placeboPlacebo for PF-06741086, single dose | Drug | Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo, Cohort 2 (SC) PF-06741086, Placebo, Cohort 3 (SC) PF-06741086, Placebo, Cohort 4 (Intravenous [IV]) PF-06741086, Placebo, Cohort 5 (IV) PF-06741086, Placebo, Cohort 6 (IV) PF-06741086, Placebo, Cohort 7 (IV) PF-06741086, Placebo |
Primary outcome
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Time frame: Day 1 up to Day 84
Percentage of subjects with laboratory abnormalities
Time frame: Day 1 up to Day 84
Number of subjects with change from baseline in vital signs
Time frame: Day 1 up to Day 84
blood pressure, pulse rate, temperature, respiration rate
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Time frame: Day 1 to Day 84
Percentage of subjects with changes from baseline in physical examination
Time frame: Day 1 to Day 84
Percentage of subjects with infusion site reactions
Time frame: Day 1 up to Day 7
Percentage of subjects with injection site reactions
Time frame: Day 1 to Day 7
18 secondary outcomes
Plasma PF-06741086 concentrations
Time frame: Day 1 up to Day 84
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 up to Day 84
Time for Cmax (Tmax)
Time frame: Day 1 up to Day 84
Area under the curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 up to Day 84
Terminal half-life (t 1/2)
Time frame: Day 1 up to Day 84
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: Day 1 up to Day 84
Volume of distribution at steady state (Vss)
Time frame: Day 1 up to Day 84
Apparent volume of distribution (Vz/F)
Time frame: Day 1 up to Day 84
Clearance (CL)
Time frame: Day 1 up to Day 84
Apparent clearance (CL/F)
Time frame: Day 1 up to Day 84
Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)]
Time frame: Day 1 up to Day 84
Mean residence time (MRT)
Time frame: Day 1 up to Day 84
Total tissue factor pathway inhibitor concentrations over time
Time frame: Day 1 up to Day 84
Thrombin generation
Time frame: Day 1 up to Day 84
Prothrombin fragment 1+2 (PF1+2) concentrations over time
Time frame: Day 1 up to Day 84
D-dimer concentrations over time
Time frame: Day 1 up to Day 84
Dilute prothrombin time (dPT)
Time frame: Day 1 up to Day 84
Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production
Time frame: Day 1 up to Day 84
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 12 Aug 2016.
- Derived from this study: PubMed 42698050Nayak S, Suzuki A, Ravva P, Raje S. Clinical Pharmacokinetics and Pharmacodynamics of Marstacimab, an Anti-tissue Factor Pathway Inhibitor Monoclonal Antibody, in Adolescent and Adult Participants with Hemophilia. Clin Pharmacokinet. 2026 Sep 4. doi: 10.1007/s40262-026-01695-5. Online ahead of print.
- 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
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-06741086 in people with Healthy, run by Pfizer at 1 site in Belgium.
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 3 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 12 Aug 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 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?
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs (time frame: Day 1 up to Day 84). The study lists 7 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 NCT02531815, 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 12 Aug 2016.