ArticleACS pharmacology & translational science2024
Model-Informed Dose Selection for a Novel Human Immunoglobulin G4 Derived Monoclonal Antibody Targeting Proprotein Convertase Kwashiorkor Type 9: Insights from Population Pharmacokinetics-Pharmacodynamics and Systems Pharmacology.
Article in ACS pharmacology & translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed, 4 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibody drugs targeting proprotein convertase kwashiorkor type 9 (PCSK9) have recently demonstrated remarkable success in lipid-lowering therapies. Specifically, antibodies derived from immunoglobulin G1 (IgG1, alirocumab) and IgG2 (evolocumab) have been successfully utilized for this purpose. Recently, a novel recombinant fully human anti-PCSK9 monoclonal antibody, originally derived from IgG4 and designated as SAL003, was developed. This study aimed to explore the pharmacokinetics, efficacy, and safety of SAL003 in both single and multiple administrations. The investigation included both healthy individuals and individuals with hyperlipidemia. To comprehensively grasp the pharmacokinetic (PK) and pharmacodynamic (PD) attributes of SAL003, this study employed population PK-PD (popPK-PD) and mechanistic systems pharmacology (MSP) modeling. These models were employed for predicting low-density lipoprotein cholesterol (LDLc) concentrations and appropriate dosages across diverse potential clinical scenarios. The research results indicated that SAL003 demonstrated comparable pharmacokinetic properties to evolocumab, exhibited notable effectiveness in reducing lipid levels, and was confirmed to be safe and well-tolerated in both healthy individuals and individuals with hyperlipidemia. Notably, SAL003 displayed differing effectiveness between patients and healthy populations. This discrepancy was observed in the popPK-PD model, with a positive population influence on
Identifiers
What OpenQuestion holds
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.