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SB12/eculizumab fixed-group PK/PD reference

Two-compartment pharmacokinetics with a direct terminal complement activity readout for specified fixed research histories.

Population pharmacokinetic, pharmacodynamic and efficacy modeling of SB12 (proposed eculizumab biosimilar) and reference eculizumab ↗

European Journal of Clinical Pharmacology

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Healthy 300 mg IV single-dose PK/PD

Fixed typical-coefficient healthy-group 300 mg instantaneous central input through 672 h.

0–672 hour

Scenario details

Healthy 300 mg IV single-dose PK/PD

Fixed typical-coefficient healthy-group 300 mg instantaneous central input through 672 h.

Readouts

Central conc · ug/mL
Deterministic model quantity in the stated physical unit.
Exposure (AUC) · ug*h/mL
Deterministic model quantity in the stated physical unit.
Peripheral conc · ug/mL
Deterministic model quantity in the stated physical unit.
Systemic clearance · L/h
Deterministic model quantity in the stated physical unit.

Study purpose

  • How do body weight and disease context change eculizumab or SB12 concentration and exposure?

Assumptions

  • Fixed typical coefficients and baseline inputs; no patient fit, random draws, population intervals or clinical dose advice.
  • Central serum concentration uses mg/L = ug/mL; the apparent peripheral compartment is not a separately measured specimen.
  • Complement activity is an algebraic direct inhibitory Hill relationship; no C5 binding or complement turnover is simulated.
  • AUC is in ug*h/mL and remains in physical hour units under alternate time displays. Elimination and exposure accounting do not feed back into PK.
  • No LDH output is provided by this model; no biological zero is substituted for an inapplicable endpoint.
  • Fixed instantaneous central inputs are specified research approximations and do not establish infusion Cmax.

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Simulation time
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h
672 → 168

Time between reported samples.

h
6 → 1

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Biology

Two-compartment pharmacokinetics with a direct terminal complement activity readout for specified fixed research histories.

Two-compartment pharmacokinetics with a direct terminal complement activity readout for specified fixed research histories.

Model details

16 parameters · 5 states · 5 equations · 38 derived outputs

Classification & API access
Therapeutic
Eculizumab, SB12
Modality
Monoclonal antibody
Target
Complement C5
Disease / scope
Healthy participants and paroxysmal nocturnal hemoglobinuria
ParameterDefaultUnitDescription
Body weightbody_weight_kg80.9kgSpecified fixed baseline input for this research context.
PD E0 healthy pctpd_e0_healthy_pct85.9percentSpecified source coefficient for this fixed context.
PD E0 pnh pctpd_e0_pnh_pct101percentSpecified source coefficient for this fixed context.
PD hillpd_hill4.56—Specified source coefficient for this fixed context.
PD IC50pd_ic50_ug_ml36.6µg/mLSpecified source coefficient for this fixed context.
PD Imax healthy fractionpd_imax_healthy_fraction0.93—Specified source coefficient for this fixed context.
PD Imax pnh fractionpd_imax_pnh_fraction0.88—Specified source coefficient for this fixed context.
PK clearancepk_cl_l_h0.0174L/hSpecified source coefficient for this fixed context.
PK clearance weight exponentpk_cl_weight_exponent1.14—Specified source coefficient for this fixed context.
PK intercompartmental clearancepk_q_l_h0.0134L/hSpecified source coefficient for this fixed context.
Central distribution volume — healthy participantspk_vc_healthy_l3.47LSpecified source coefficient for this fixed context.
Central distribution volume — PNHpk_vc_pnh_l5.68LSpecified source coefficient for this fixed context.
PK central distribution volume weight exponentpk_vc_weight_exponent0.863—Specified source coefficient for this fixed context.
PK peripheral distribution volumepk_vp_l0.79LSpecified source coefficient for this fixed context.
PK weight referencepk_weight_ref_kg80.9kgSpecified source coefficient for this fixed context.
Pnh patient flagpnh_patient_flag0—Specified fixed baseline input for this research context.

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