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Antibody exposure and mixed IL13 assay signal

Apparent subcutaneous MEDI7836 exposure drives IL13 turnover and reversible complex formation. Free cytokine and a detected complex fraction contribute to a conditional mixed assay signal.

Pharmacokinetic-Pharmacodynamic Modelling of Systemic IL13 Blockade by Monoclonal Antibody Therapy: A Free Assay Disguised as Total ↗
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Fixed 30 mg exposure

How do free cytokine and mixed assay signal respond to fixed subcutaneous exposure and clearance?

0–280 d

Study

Fixed 30 mg exposure

How do free cytokine and mixed assay signal respond to fixed subcutaneous exposure and clearance?

Readouts

Drug serum· nmol/L
Conditional concentration in nmol/L; source observation coordinates retained.
Target free· nmol/L
Conditional concentration in nmol/L; source observation coordinates retained.
Complex serum· nmol/L
Conditional concentration in nmol/L; source observation coordinates retained.
Assay signal· nmol/L
Conditional concentration in nmol/L; source observation coordinates retained.

Study purpose

  • How do free cytokine and mixed assay signal respond to fixed subcutaneous exposure and clearance?

Interpretation limits

  • Conditional fixed-effect single-dose exploration in healthy adult volunteers; no clinical dosing, efficacy, safety, original population or patient-level prediction.
  • Apparent drug PK is an independent linear driver. Complex formation does not subtract central drug; the drug-driver ledger is not total chemical antibody conservation.
  • The literal supplement uses separate complex kinetic and observation volumes. Its main-vector untreated observation is about 0.034 pM, whereas the article reports 0.096 pM; neither value is adjusted to hide the discrepancy.
  • The main bootstrap-median vector and two printed SI starting/fixed vectors remain separate. Initial target is kin/kout. All context parameters except effective apparent clearance stay fixed.
  • The ADA configurations apply the reported fixed clearance shift once. Editing effective clearance is an exploratory coefficient change, not an ADA-status or population estimate.
  • Clearance bounds are authored 0.5–1.5× the extrema of the retained effective clearances. They are exploratory bounds, not confidence intervals or clinical limits.
  • Changing the simulation start uses the supplied initial state at that start and does not reconstruct earlier doses. The declared dose observation sides remain explicit.
  • No source figure panel, population fit, residual likelihood, repeated-dose prediction or original patient observations are reproduced. Fitting and normal server scans are unavailable.
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Antibody clearance

Effective CL/F after the selected fixed ADA context. Exploratory 0.5–1.5× retained extrema; changing it does not re-estimate ADA status. Initial target and volumes remain fixed.

L/d
0.441 → —
Simulation time
d
d
280 → 168

Time between reported samples.

d

1 change · Variation 1

Continue in the background and keep the result.

Biology

Apparent subcutaneous MEDI7836 exposure drives IL13 turnover and reversible complex formation. Free cytokine and a detected complex fraction contribute to a conditional mixed assay signal.

Apparent subcutaneous MEDI7836 exposure drives IL13 turnover and reversible complex formation. Free cytokine and a detected complex fraction contribute to a conditional mixed assay signal.
States & equation dependencies
Representative technical topology with 10 selected states: Central-compartment amount, Complex, Complex eliminated, Complex peripheral, Administration-site amount, Drug eliminated, Peripheral-compartment amount, Target, Target eliminated, Target produced. Displayed equation-linked dependencies: from Administration-site amount to Central-compartment amount; between Peripheral-compartment amount and Central-compartment amount; from Central-compartment amount to Complex; between Complex peripheral and Complex; between Target and Complex; from Complex to Complex eliminated; from Central-compartment amount to Drug eliminated; from Central-compartment amount to Target; from Target to Target eliminated. Displayed model or scenario entry points: Administered input enters Administration-site amount. There are no separately labeled equation controls. 10 of 10 runtime states are shown. Dashed arrows are equation dependencies, not material transfer. Every declared dosing target is included.
Open full technical diagram
Teal arrows show relationships between modeled states and do not always represent material transfer. Peach arrows mark administered or scenario-defined entry points.

Assumptions & evidence

Assumptions & limitations

  • Conditional fixed-effect single-dose exploration in healthy adult volunteers; no clinical dosing, efficacy, safety, original population or patient-level prediction.
  • Apparent drug PK is an independent linear driver. Complex formation does not subtract central drug; the drug-driver ledger is not total chemical antibody conservation.
  • The literal supplement uses separate complex kinetic and observation volumes. Its main-vector untreated observation is about 0.034 pM, whereas the article reports 0.096 pM; neither value is adjusted to hide the discrepancy.
  • The main bootstrap-median vector and two printed SI starting/fixed vectors remain separate. Initial target is kin/kout. All context parameters except effective apparent clearance stay fixed.
  • The ADA configurations apply the reported fixed clearance shift once. Editing effective clearance is an exploratory coefficient change, not an ADA-status or population estimate.
  • Clearance bounds are authored 0.5–1.5× the extrema of the retained effective clearances. They are exploratory bounds, not confidence intervals or clinical limits.
  • Changing the simulation start uses the supplied initial state at that start and does not reconstruct earlier doses. The declared dose observation sides remain explicit.
  • No source figure panel, population fit, residual likelihood, repeated-dose prediction or original patient observations are reproduced. Fitting and normal server scans are unavailable.

Parameter origins

  • Released executable model definition; exact publication locator not reported

Validation & references

One or more implementation checks are available; this is not a claim of full model reproduction.

Pharmacokinetic-Pharmacodynamic Modelling of Systemic IL13 Blockade by Monoclonal Antibody Therapy: A Free Assay Disguised as Total ↗

Available reference curves can be added to the plot when their scenario, readout, time and units match.

Model details

11 parameters · 10 states · 10 equations · 12 derived outputs

Classification & API access
Therapeutic
MEDI7836
Modality
Monoclonal antibody
Target
IL13
Disease / scope
healthy adult volunteers
ParameterDefaultUnitDescription
Systemic clearancecl0.441L/dEffective CL/F after the selected fixed ADA context. Exploratory 0.5–1.5× retained extrema; changing it does not re-estimate ADA status. Initial target and volumes remain fixed.
Fracfrac0.04291Fixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Absorption rate constantka0.1561/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Kinkin0.0173nmol/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Dissociation ratekoff0.691/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Association ratekon138.24L/nmol/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Turnover loss ratekout1801/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Intercompartmental clearanceq0.825L/dFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Central distribution volumevc2.83LFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Vcxvcx13.6LFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.
Peripheral distribution volumevp8.03LFixed conditional estimate. Envelope covers retained private configurations only; not a public fitting or scan bound.

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