Evidence map›Paper›PMID 40838600›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2025

Population Pharmacokinetic Model of Pegbing in Healthy Subjects and Chronic Hepatitis B Patients.

Weizhe Jian, Yalin Yin, Rong Chen, Pingyao Luo, Tianyu Wang, Jianbo Gu, Zhengfang Du, Lei Cai, Tianyu Bao, Junsheng Xue and 2 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

12 authors.

Weizhe JianDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Yalin YinXiamen Amoytop Biotech Co., LTD, Xiamen, China.
Rong ChenDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Pingyao LuoDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Tianyu WangDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Jianbo GuXiamen Amoytop Biotech Co., LTD, Xiamen, China.
Zhengfang DuXiamen Amoytop Biotech Co., LTD, Xiamen, China.
Lei CaiDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Tianyu BaoDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Junsheng XueDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Ruoyi HeXiamen Amoytop Biotech Co., LTD, Xiamen, China.
Tianyan ZhouDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing, China.ORCID 0000-0003-2583-8080

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pegbing (peginterferon alpha-2b) is a polyethylene glycol-modified interferon α-2b injection that has demonstrated favorable efficacy and safety profiles in the treatment of chronic hepatitis B (CHB). This study aimed to develop a population pharmacokinetic (PopPK) model of Pegbing in both healthy subjects and CHB patients and to investigate the influence of covariates on its pharmacokinetic behavior. Pharmacokinetic data were obtained from a Phase I trial in healthy volunteers and a Phase II trial in CHB patients. A one-compartment model with a target-mediated drug disposition (TMDD) component incorporating IFN receptor downregulation was established to describe the pooled data from 28 healthy subjects and 39 CHB patients. Physiologically reasonable parameters were estimated, providing a good description and prediction of the model. Furthermore, the final PopPK model was externally validated using an independent dataset of 115 CHB patients. In the covariate analysis, health status (healthy v.s. CHB) was a significant covariate, affecting the Pegbing absorption rate, creatinine clearance was associated with clearance, and body weight affected the volume of distribution. Compared with healthy subjects, CHB patients exhibited a consistent area under the curve (AUC) but a higher C

Indexed as

Antiviral AgentsHepatitis B, ChronicInterferon-alphaModels, BiologicalPolyethylene GlycolsAdultArea Under CurveFemaleHealthy VolunteersHumansInterferon alpha-2MaleMiddle AgedRecombinant ProteinsYoung AdultAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant Proteinschronic hepatitis Bmodel‐informed drug developmentpegylated interferon‐αpopulation pharmacokinetic modeltarget‐mediated drug disposition

Identifiers

PMID40838600
PMCPMC12706394

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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.