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Healthy VolunteersPhase 1NCT04832139

A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device

A Phase 1 study testing Marstacimab PFP and Marstacimab PFS in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe. 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 Volunteers
What is being tested?
Marstacimab PFP and Marstacimab PFS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteBelgium
Study dates
30 Mar 2021to 22 Nov 2021
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

  • Male participants who are overtly healthy as determined by medical evaluation
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight ≥ 50 kg (110 lb).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
  • Any condition possibly affecting drug absorption (eg, conditions affecting SC administration)
  • Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality or COVID-19 related condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
Show all 26Show fewer
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test at screening and/or admission
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening:
  • AST or ALT level ≥1.5 × ULN;
  • Total bilirubin level ≥1.5 × ULN.
  • An estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 based on the CKD-EPI equation.
  • Resistance to activated protein C (or Factor V Leiden mutation), prothrombin 20210 mutation, antithrombin III deficiency, protein C deficiency, or protein S deficiency.
  • Presence of Lupus anticoagulant anti-cardiolipin antibodies (IgG, IgM or IgA)
  • High sensitivity C-reactive protein (hsCRP) above the upper limits of normal
  • Abnormal hematology values as defined by the following laboratory tests at Screening and/or admission:
  • Platelet count <100,000/uL
  • Hemoglobin level <10 g/dL
  • A positive COVID-19 test.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
  • Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Brussels Clinical Research Unit

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF MARSTACIMAB (PF-06741086) PREFILLED SYRINGE DEVICE AND PREFILLED PEN DEVICE FOLLOWING SUBCUTANEOUS ADMINISTRATION IN HEALTHY ADULT MALE PARTICIPANTS

The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.

Being tested
Marstacimab PFP, Marstacimab PFS
Keywords
Bioequivalence, Phase 1, Prefilled Pen, Prefilled syringe, pharmacokinetic, subcutaneous, hemophilia
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Marstacimab PFPDrug

    Also called PF-06741086

    300 milligrams (mg) subcutaneous injection marstacimab PFP

  • Marstacimab PFSDrug

    Also called PF-06741086

    300 mg subcutaneous injection of marstacimab PFS

Study groups in NCT04832139
Study groupRoleWhat they receive
Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS)ExperimentalParticipants will first receive single dose PFP, then PFS, then repeating single dose PFP, then single dose PFS with a minimum of 21 days between single doses.
Receives: Drug: Marstacimab PFP; Drug: Marstacimab PFS
Marstacimab PFS, then marstacimab PFPExperimentalParticipants will first receive single dose PFS, then PFP, then repeating single dose PFS, then single dose PFP with a minimum of 21 days between single doses.
Receives: Drug: Marstacimab PFP; Drug: Marstacimab PFS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf)

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  2. Maximum observed plasma concentration (Cmax)

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

Secondary outcomes (10)

  1. Area under the concentration time curve from time 0 to time of last quatifiable concenteration

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  2. Time for Cmax

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  3. Apparent clearance after subcutaneous dose

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  4. Apparent volume of distribution after subcutaneous dose

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  5. Terminal half-life after subcutaneous dose

    Measured: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose

  6. Incidence of clinically significant laboratory value abnormalities

    Measured: Baseline through the end of study, approximately 161 days

  7. Incidence of anti-drug antibody against marstacimab

    Measured: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days

  8. Incidence of Adverse Events

    Measured: Baseline through the end of study, approximately 161 days

  9. Incidence of neutralizing antibody against marstacimab

    Measured: From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days

  10. Incidence of Serious Adverse Events

    Measured: Baseline through the end of study, approximately 161 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start30 Mar 2021
  3. Primary completion22 Nov 2021
  4. Study completion22 Nov 2021

Why it stopped: The study was terminated due to a change in the benefit/risk assessment for the further administration of marstacimab in a healthy volunteer population.

Resources

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
Crossover
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832139
Sponsor's protocol ID
B7841009
Other IDs
2020-004369-38
Status last verified
Jul 2022
First submitted
26 Mar 2021
Last updated
11 Jul 2022
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Marstacimab PFP and Marstacimab PFS in people with Healthy Volunteers, 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 4 inclusion and 26 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: stopped early, as of the sponsor's last update on 11 Jul 2022. 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 was stopped early (reason given: The study was terminated due to a change in the benefit/risk assessment for the further administration of marstacimab in a healthy volunteer population.). Results are not available in the source record.

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?

Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf) (time frame: Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose). 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 NCT04832139, 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 11 Jul 2022.

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