Trial reportPharmaceutical research1998
Pharmacokinetics and leukocyte responses of recombinant human interleukin-10.
Trial report in Pharmaceutical research, 1998. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
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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
23 citing papers in PubMed, 72 citations in OpenAlex.
- Pharmacokinetic and pharmacodynamic relationship of AMG 811, an anti-IFN-γ IgG1 monoclonal antibody, in patients with systemic lupus erythematosus.Pharmaceutical research · 2015Trial
- Population pharmacokinetics of onercept in healthy subjects.Clinical pharmacokinetics · 2005Trial
- Prolonged Release of IL-10 From Enzyme-Mediated Poly-l-(Tyrosine-co-Phenylalanine) Nanocrystals Enhances Stability and Modulates Inflammatory Responses.Biopolymers · 2026Article
- Mineral coated microparticles delivering Interleukin-4, Interleukin-10, and Interleukin-13 reduce inflammation and improve function after spinal cord injury in a rat.Experimental neurology · 2025Article
- Ex vivo delivery of recombinant IL-10 to human donor lungs.JHLT open · 2025Article
- The Role of Interleukin-10 in the Pathogenesis and Treatment of a Spinal Cord Injury.Diagnostics (Basel, Switzerland) · 2024Review
- Improving outcomes in intracerebral hemorrhage through microglia/macrophage-targeted IL-10 delivery with phosphatidylserine liposomes.Biomaterials · 2023Article
- Lymphatic Distribution of Etanercept Following Intravenous and Subcutaneous Delivery to Rats.Pharmaceutical research · 2020Article
- Immune regulation and cytotoxic T cell activation of IL-10 agonists - Preclinical and clinical experience.Seminars in immunology · 2019Review
- Sustained interleukin-10 delivery reduces inflammation and improves motor function after spinal cord injury.Journal of neuroinflammation · 2019Article
- A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins.The AAPS journal · 2016Article
- Mechanistic determinants of biotherapeutics absorption following SC administration.The AAPS journal · 2012Review
- Pharmacokinetics, lymph node uptake, and mechanistic PK model of near-infrared dye-labeled bevacizumab after IV and SC administration in mice.The AAPS journal · 2012Article
- Pharmacokinetic/pharmacodynamic modeling in inflammation.Critical reviews in biomedical engineering · 2012Review
- Interspecies scaling and prediction of human clearance: comparison of small- and macro-molecule drugs.Xenobiotica; the fate of foreign compounds in biological systems · 2011Article
- IL-10 within the CNS is necessary for CD4+ T cells to mediate neuroprotection.Brain, behavior, and immunity · 2011Article
- Flip-flop pharmacokinetics--delivering a reversal of disposition: challenges and opportunities during drug development.Therapeutic delivery · 2011Review
- Scaling pharmacodynamics from in vitro and preclinical animal studies to humans.Drug metabolism and pharmacokinetics · 2009Review
- Role of IL-10 in the resolution of airway inflammation.Current molecular medicine · 2008Review
- Population pharmacokinetics of darbepoetin alfa in healthy subjects.British journal of clinical pharmacology · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo study the pharmacokinetics and ex vivo leukocyte responses of recombinant human IL-10 (rHuIL-10) following single s.c. and i.v. dosing.
methodsA randomized two-way cross-over study was undertaken in 17 healthy volunteers in which rHuIL-10 was administered as 25 microg/kg s.c. and i.v. doses. Blood samples were collected for 48 hr after dosing to determine serum IL-10 concentrations. Inhibitory activity of IL-10 on ex vivo production of inflammatory cytokines (TNF-alpha and IL-1beta) by LPS-treated peripheral blood cells were measured over 96 hr.
resultsA physiologically-relevant modeling approach was developed to determine the pharmacokinetics for two routes of administration (s.c. and i.v.). The i.v. dose showed polyexponential disposition with CL of 65 mL/kg/hr, Vss of 70 mL/kg, and t1/2 of 1.94 hr. Absolute bioavailability averaged 42% for s.c. dosing which produced lower but sustained concentrations. Substantial and prolonged suppression of TNF-alpha and IL-1beta production was achieved during IL-10 treatment. The Hill Function was used to account for the joint concentration-dependent immunosuppressive action of rHuIL-10 after both i.v. and s.c. doses. The IC50 values were about 0.03 ng/ml and Imax values were about 0.85 for both TNF-alpha and IL-1beta suppression. The degree of change as well as the duration of leukocyte response was greater after s.c. administration than after i.v. administration.
conclusionrHuIL-10 shows favorable PKPD characteristics especially by the s.c. route of administration which produced prolonged suppression of cytokine production (ex vivo) which may be applicable in various immune-related disorders.
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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.