Evidence map›Paper›PMID 29885068›Full record

Trial reportBritish journal of clinical pharmacology2018

A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.

Valerie Cuvier, Ulrike Lorch, Stephan Witte, Aurelie Olivier, Sebastien Gibot, Isabelle Delor, Jean-Jacques Garaud, Marc Derive, Margarita Salcedo-Magguilli

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03463044 (A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT03463044 phase1completednot on this map

A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM (LR12) in Healthy Male Subjects

TypeinterventionalSponsorInotremRan2016 to 2016Enrolled27ConditionsHealthy SubjectsArmsnangibotide, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Tissue-resident CCR2Cell reports · 2025
    Article
  6. Review
  7. Anti-DAMP therapies for acute inflammation.Frontiers in immunology · 2025
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review of potential medical treatments for middle ear cholesteatoma.Cell communication and signaling : CCS · 2022
    Review
  17. Article
  18. TREM-1 Modulation Strategies for Sepsis.Frontiers in immunology · 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 4 institutions in 2 countries.

Valerie CuvierInotrem, Paris, France.
Ulrike LorchRichmond Pharmacology, St George's University of London, London, UK.ORCID 0000-0002-6316-5860
Stephan WitteInotrem, Paris, France.
Aurelie OlivierInotrem, Paris, France.
Sebastien GibotICU Hospital Central, Nancy, France.
Isabelle DelorMnS Modeling and Simulation, Dinant, Belgium.
Jean-Jacques GaraudInotrem, Paris, France.
Marc DeriveInotrem, Paris, France.ORCID 0000-0002-8707-5923
Margarita Salcedo-MagguilliInotrem, Paris, France.
Délégation Paris 7 · FRCentre Hospitalier Régional et Universitaire de Nancy · FRSt George's, University of London · GBSystem Simulation (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe peptide nangibotide is the first clinical-stage agent targeting the immunoreceptor TREM-1 (triggering receptor expressed on myeloid cells-1) and is being investigated as a novel therapy for acute inflammatory disorders such as septic shock. This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.

methodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a single continuous intravenous infusion. The first two groups received a single i.v. dose of 1 and 10 mg, respectively, over 15 min. Subsequent groups were randomized in a product : placebo ratio of 3:1 at doses ranging from 0.03 to 6 mg kg

resultsNangibotide was safe and well tolerated up to the highest dose tested. There were only few adverse events and they were mild in severity and considered unrelated to treatment. Nangibotide displayed dose-proportional PK properties, with a clearance of 6.6 l kg

conclusionsThe novel immunomodulator nangibotide displayed favourable safety and PK profiles at all doses, including expected pharmacologically active doses, and warrants further clinical development.

Indexed as

AdultArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodDrugs, InvestigationalHalf-LifeHealthy VolunteersHumansImmunity, InnateImmunologic FactorsInfusions, IntravenousMaleMetabolic Clearance RatePeptidesTriggering Receptor Expressed on Myeloid Cells-1Young AdultDrugs, InvestigationalImmunologic FactorsPeptidesTREM1 protein, humanTriggering Receptor Expressed on Myeloid Cells-1drug safetypharmacokineticsPhase Irandomized controlled trial

Identifiers

PMID29885068
PMCPMC6138490
OpenAlexW2805631143

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.