Evidence map›Paper›PMID 38558535›Full record

Trial reportClinical and translational science2024

Pharmacokinetics, pharmacodynamics, and safety of frunexian in healthy Chinese volunteer adults: A randomized dose-escalation phase I study.

Jia-Yu Zhang, Zou-Rong Ruan, Bo Jiang, Dan-Dan Yang, Jia-Ying Wang, Yin Hu, Yong-Rui Wang, Yan-Mei Wang, Yun-Fei Lin, Ling-Ling Wang and 1 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 19% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. 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

11 authors at 1 institution in 1 country.

Jia-Yu ZhangCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0002-5221-0232
Zou-Rong RuanCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.
Bo JiangCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0003-2406-0959
Dan-Dan YangCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.ORCID 0009-0007-7168-0364
Jia-Ying WangCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0003-0183-9484
Yin HuCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.
Yong-Rui WangSichuan Haisco Pharmaceutical Co., Ltd., Chengdu, China.ORCID 0009-0000-6899-0328
Yan-Mei WangSichuan Haisco Pharmaceutical Co., Ltd., Chengdu, China.ORCID 0009-0001-9202-7934
Yun-Fei LinSichuan Haisco Pharmaceutical Co., Ltd., Chengdu, China.ORCID 0009-0001-8707-5640
Ling-Ling WangSichuan Haisco Pharmaceutical Co., Ltd., Chengdu, China.ORCID 0009-0002-3434-5501
Hong-Gang LouCenter of Clinical Pharmacology, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0002-8263-3674
Second Affiliated Hospital of Zhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of frunexian (formerly known as EP-7041 and HSK36273) injection, a small molecule inhibitor of activated coagulation factor XI (FXIa), in healthy Chinese adult volunteers. This study was a randomized, placebo- and positive-controlled, sequential, ascending-dose (0.3/0.6/1.0/1.5/2.25 mg/kg/h) study of 5-day continuous intravenous infusions of frunexian. Frunexian administration exhibited an acceptable safety profile with no bleeding events. Steady state was rapidly reached with a median time ranging from 1.02 to 1.50 h. The mean half-life ranged from 1.15 to 1.43 h. Frunexian plasma concentration at a steady state and area under the concentration-time curve exhibited dose-proportional increases. The dose-escalation study of frunexian demonstrated its progressively enhanced capacities to prolong activated partial thromboplastin time (aPTT) and inhibit FXIa activity. The correlations between PK and PD biomarkers (aPTT/baseline and FXI clotting activity/baseline) were described by the two E

Indexed as

AnticoagulantsBlood CoagulationAdultChinaDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansPartial Thromboplastin TimeAnticoagulants

Identifiers

PMID38558535
PMCPMC10983022
OpenAlexW4393380441

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.