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NCT02531815
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
Phase 1 trial testing PF-06741086 in Healthy in 41 participants. Completed in 1 July 2016.
1 July 2016
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 41 |
| Start date | 1 August 2015 |
| Primary completion | 1 July 2016 |
| Estimated completion | 1 July 2016 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- PF-06741086 (pf-06741086) — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Molecular Revolution in the Treatment of Hemophilia.
Butterfield JSS, Hege KM, Herzog RW, Kaczmarek R. · · 2020 · cited 76× · PMID 31843450 · DOI 10.1016/j.ymthe.2019.11.006 -
Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management.
Mahlangu JN. · · 2021 · cited 18× · PMID 34026796 · DOI 10.3389/fmed.2021.670526 -
Marstacimab for the Treatment of Hemophilia A or B.
Mahlangu J. · · 2025 · cited 2× · PMID 40584300 · DOI 10.2147/btt.s500480 -
Absence of Effect of Emicizumab on D-Dimer Concentrations in Adult Patients with Severe Hemophilia A.
Iarossi M, Lambert C, Hermans C. · · 2022 · cited 1× · PMID 36474347 · DOI 10.1177/10760296221143382
Verify or expand the search:
- PubMed search for NCT02531815
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PF-06741086
Trials testing the same drug.
- NCT05145127 — Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors · Phase 3 · recruiting
- NCT04878731 — Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemo · Phase 1 · completed
- NCT03938792 — Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Se · Phase 3 · completed
- NCT03363321 — PF-06741086 Long-term Treatment in Severe Hemophilia · Phase 2 · completed
- NCT02974855 — PF-06741086 Multiple Dose Study in Severe Hemophilia · Phase 2 · completed
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Other Pfizer trials
Trials by the same sponsor.
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- NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
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- NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
- NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02531815 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 10 August 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02531815.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing