Evidence map›Paper›PMID 25714598›Full record

Trial reportJournal of cardiovascular pharmacology2015

First-in-Man Study With Inclacumab, a Human Monoclonal Antibody Against P-selectin.

Christophe Schmitt, Markus Abt, Cornelia Ciorciaro, Dorothee Kling, Candice Jamois, Eginhard Schick, Corinne Solier, Renée Benghozi, Jacques Gaudreault

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of cardiovascular pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
2.2field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Targeting the 5-HTActa pharmacologica Sinica · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. P- and E- selectin in venous thrombosis and non-venous pathologies.Journal of thrombosis and haemostasis : JTH · 2022
    Review
  18. PlateletCells · 2022
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Christophe Schmitt*F. Hoffmann-La Roche AG, Basel, Switzerland; and †JJG Pharma Consulting, GmbH, Basel, Switzerland.
Markus Abt
Cornelia Ciorciaro
Dorothee Kling
Candice Jamois
Eginhard Schick
Corinne Solier
Renée Benghozi
Jacques Gaudreault
Roche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Inclacumab, a novel monoclonal antibody against P-selectin in development for the treatment and prevention of atherosclerotic cardiovascular diseases, was administered in an ascending single-dose study as intravenous infusion to evaluate safety, pharmacokinetics, and pharmacodynamics. Fifty-six healthy subjects were enrolled in this randomized, double-blind placebo-controlled study. Each dose level (0.03-20 mg/kg) was investigated in separate groups of 8 subjects (6 on inclacumab, 2 on placebo). Platelet-leukocyte aggregates, free/total soluble P-selectin concentration ratio, drug concentrations, bleeding time, platelet aggregation, antibody formation, and routine laboratory parameters were measured frequently until 32 weeks. Pharmacokinetic profiles were indicative of target-mediated drug disposition. Platelet-leukocyte aggregate inhibition and soluble P-selectin occupancy showed dose dependency and were strongly correlated to inclacumab plasma concentrations, with IC50 of 740 and 4600 ng/mL, respectively. Inclacumab was well tolerated by the majority of subjects and did neither affect bleeding time nor platelet aggregation. These findings allowed the investigation of the potential beneficial therapeutic use of inclacumab in patient study.

Indexed as

AdultAntibodies, MonoclonalBleeding TimeCardiovascular AgentsDouble-Blind MethodEnglandFemaleHealthy VolunteersHemorrhageHumansInfusions, IntravenousMaleMiddle AgedPlatelet AggregationPredictive Value of TestsP-SelectinAntibodies, MonoclonalCardiovascular AgentsinclacumabP-SelectinSELP protein, human

Identifiers

PMID25714598
PMCPMC4461388
OpenAlexW2075781353

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.