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Table 2 Estimates of PK parameters of VRC07-523LS from a base two-compartment popPK model

From: Pharmacokinetic interaction assessment of an HIV broadly neutralizing monoclonal antibody VRC07-523LS: a cross-protocol analysis of three phase 1 trials in people without HIV

Parameter

Description

Estimate

95% CI

% RSE

Fixed Effects

 F

Bioavailability

0.47

(0.45, 0.49)

2.50

 Ka (/day)

Absorption rate constant

0.34

(0.27, 0.43)

11.75

 CL (L/day)

Clearance rate

0.12

(0.11, 0.13)

2.61

 Vc (L)

Central volume

3.88

(3.56, 4.23)

4.36

 Q (L/day)

Inter-compartmental clearance

0.30

(0.26, 0.35)

7.83

 Vp (L)

Peripheral volume

3.60

(3.34, 3.89)

3.85

Random Effects

 ωCL

SD, clearance

0.29

(0.25, 0.33)

6.52

 ωVc

SD, central volume

0.40

(0.34, 0.46)

7.44

 ωQ

SD, inter-compartmental clearance

0.57

(0.45, 0.73)

12.65

 ωVp

SD, peripheral volume

0.24

(0.19, 0.29)

10.57

Error Model Parameters

 σ1

SE, additive error

0.13

(0.09, 0.19)

20.39

 σ2

SE, proportional error

0.14

(0.13, 0.15)

3.45

  1. The model included serum concentrations from 146 participants who received intravenous or subcutaneous VRC07-523LS alone (n = 46) or in combination with other mAbs (n = 100) across three phase 1 clinical trials. No covariates were adjusted for in the base popPK model
  2. Abbreviations: CI confidence interval, %RSE % relative standard error, SD standard deviation, SE standard error