Evidence map›Paper›PMID 40252193›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2025

A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects.

Ying Wang, Yuanzhi Cheng, Yuhan Guo, Yang Fan, Renpeng Zhou, Qian Zhang, Ye Xu, Sheng Feng, Kai Shen, Wei Hu

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05370950 (A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05370950 phase1completednot on this map

A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2022 to 2022Enrolled159ConditionsHypercholesterolemia and HyperlipidemiaArmsSHR-1209
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025
    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

10 authors.

Ying Wang *Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Yuanzhi Cheng *Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Yuhan GuoClinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Yang FanClinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Renpeng ZhouDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Qian ZhangDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Ye XuClinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Sheng FengClinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Kai ShenClinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. CP.Publication@hengrui.com.ORCID http://orcid.org/0009-0009-0439-635X
Wei HuDepartment of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China. huwei@ahmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesRecaticimab (SHR-1209) is a humanized monoclonal antibody that binds to the proprotein convertase subtilisin/kexin type 9 (PCSK9) with high affinity. This study was conducted to compare the relative bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), and safety of recaticimab following subcutaneous injection at three different sites in healthy Chinese subjects.

methodsIn this randomized, parallel, open-label, phase I study, 159 healthy Chinese subjects were randomized to receive a single dose of 450 mg recaticimab subcutaneously into the abdomen, upper-arm, or thigh and were followed up until 113 days postdose. Adverse events were monitored, and serum samples were collected for PK, PD, and immunogenicity evaluation during the study.

resultsThe PK profiles of recaticimab were similar among different injection site groups. The geometric mean ratios of maximum serum concentration (C

conclusionsA single subcutaneous injection of 450 mg recaticimab into the abdomen, upper-arm, or thigh was well-tolerated and presented similar PK and PD profiles, which supported the interchangeable use of the three injection sites for patients. CLINICAL TRIAL IDENTIFIER: ( www. CLINICALTRIALS: gov ) NCT05370950 2022-05-07.

Indexed as

Antibodies, Monoclonal, HumanizedAdultArea Under CurveBiological AvailabilityChinaEast Asian PeopleFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedProprotein Convertase 9Young AdultAntibodies, Monoclonal, HumanizedPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID40252193

What Socratic 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 Socratic graph.