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NCT04266301 · OUTCOME

Pharmacokinetics of MBG453 (Parameter Cmax)

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
ug/ml
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0 hr (pre-dose) & 2 hrs (post-dose) of Cycle (C) 1 Day (D) 8 and 0 hr (pre-dose) & 2 hrs (post-dose) of C3D8

What was measured

Cmax is the maximum (peak) observed drug concentration after single dose administration (mass x volume-1).

Analysis population: Pharmacokinetic Analysis Set (PAS) included all participants in the Safety Set, who had at least one evaluable PK concentration. Safety Set included all participants who received at least one dose of any component of the study treatment, and they were analyzed according to the study treatment they received.

Groups in this outcome

Sabatolimab (MBG453)

Participants received sabatolimab.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453)8

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453)8
Values in ug/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453)23220.9Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453)6
Values in ug/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453)23939.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.9
        value
        232
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.5
        value
        239
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Cmax is the maximum (peak) observed drug concentration after single dose administration (mass x volume-1).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received sabatolimab.
    id
    OG000
    title
    Sabatolimab (MBG453)
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set (PAS) included all participants in the Safety Set, who had at least one evaluable PK concentration. Safety Set included all participants who received at least one dose of any component of the study treatment, and they were analyzed according to the study treatment they received.
reporting Status
POSTED
time Frame
0 hr (pre-dose) & 2 hrs (post-dose) of Cycle (C) 1 Day (D) 8 and 0 hr (pre-dose) & 2 hrs (post-dose) of C3D8
title
Pharmacokinetics of MBG453 (Parameter Cmax)
type
SECONDARY
unit Of Measure
ug/ml

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice