Evidence map›Paper›PMID 39308062›Full record

Trial reportPharmacology research & perspectives2024

Pharmacokinetics and pharmacodynamics of the factor XIa-inhibiting antibody osocimab in healthy male East Asian volunteers: Results from two phase 1 studies.

Zhili Dong, Kensei Hashizume, Frauke Friedrichs, Pei Liu, Toshiaki Tanaka, Yuqin Liao

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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

6 authors.

Zhili DongClinical Pharmacology Asia, Bayer Healthcare Company Ltd, Shanghai, China.
Kensei HashizumeClinical Pharmacology, Translational Sciences, Research & Development Japan, Bayer Yakuhin, Ltd, Tokyo, Japan.
Frauke FriedrichsResearch & Early Development Statistics, Bayer AG, Wuppertal, Germany.
Pei LiuClinical Pharmacology Asia, Bayer Healthcare Company Ltd, Beijing, China.ORCID 0009-0003-2434-7164
Toshiaki TanakaClinical Pharmacology, Translational Sciences, Research & Development Japan, Bayer Yakuhin, Ltd, Tokyo, Japan.ORCID 0009-0004-9857-173X
Yuqin LiaoClinical Statistics & Analytics China, Bayer Healthcare Company Ltd, Beijing, China.

Funding

Bayer AG, Berlin, Germany
6 · The paper itself

Abstract

The pharmacokinetics, pharmacodynamics, immunogenicity, and safety of osocimab single doses in healthy Chinese and Japanese volunteers over 149 days were evaluated. Two phase 1 single-blinded, placebo-controlled studies with 27 Japanese and 50 Chinese participants were conducted. Osocimab was investigated with IV doses of 0.3, 1.25, and 2.5 mg/kg (Chinese study) and 0.3, 1.25, and 5.0 mg/kg (Japanese study), as well as SC doses of 3.0 and 6.0 mg/kg (Chinese study) and 6.0 mg/kg (Japanese study). The maximum plasma concentration was reached 1-3 h and 4-6 days after IV and SC administration, respectively. Osocimab exhibited a deviation from dose-proportional pharmacokinetics for AUC but not C

Indexed as

Dose-Response Relationship, DrugHealthy VolunteersAdultAntibodies, Monoclonal, HumanizedArea Under CurveEast Asian PeopleFactor XIaHumansInjections, SubcutaneousMaleMiddle AgedPartial Thromboplastin TimeSingle-Blind MethodYoung AdultAntibodies, Monoclonal, HumanizedFactor XIaosocimabcardiovascular pharmacologypharmacokineticsphase I

Identifiers

PMID39308062
PMCPMC11417140

What OpenQuestion holds

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Registered trials

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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.