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NCT04420689 · OUTCOME

Time of Peak ALM-488 Concentration in Plasma (Cmax)

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Source last updated 2025-05-08

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

Measure
MEAN
Unit
hours
Interval / dispersion
Standard Deviation
Time frame
28 (+5) days

What was measured

Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours).

Analysis population: Patients were accrued into the Dose Defining Cohorts (Dose Escalation/De-Escalation) and the Dose Timing Cohorts using inclusion and exclusion criteria as specified in the protocol.

Groups in this outcome

Dose Defining 100mg

This arm of the study will include Dose Defining 100mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 200mg

This arm of the study will include Dose Defining 200mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 400mg

This arm of the study will include Dose Defining 400mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 500mg

This arm of the study will include Dose Defining 500mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 600mg

This arm of the study will include Dose Defining 600mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Timing 1-3hrs

This arm of the study will include Dose timing of ALM-488 administration 1-3hrs before surgery cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Timing 3-5 Hours.

This arm of the study will include Dose timing of ALM-488 administration 3-5hrs before surgery cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

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

Analysis denominator · Participants

GroupSource count
Dose Defining 100mg3
Dose Defining 200mg3
Dose Defining 400mg3
Dose Defining 500mg3
Dose Defining 600mg3
Dose Timing 1-3hrs6
Dose Timing 3-5 Hours.6

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Defining 100mg0.500.00Not reportedNot reportedNot reported
Dose Defining 200mg0.500.00Not reportedNot reportedNot reported
Dose Defining 400mg0.500.00Not reportedNot reportedNot reported
Dose Defining 500mg0.420.14Not reportedNot reportedNot reported
Dose Defining 600mg0.420.14Not reportedNot reportedNot reported
Dose Timing 1-3hrs0.420.13Not reportedNot reportedNot reported
Dose Timing 3-5 Hours.0.400.14Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        0.50
      2. group Id
        OG001
        spread
        0.00
        value
        0.50
      3. group Id
        OG002
        spread
        0.00
        value
        0.50
      4. group Id
        OG003
        spread
        0.14
        value
        0.42
      5. group Id
        OG004
        spread
        0.14
        value
        0.42
      6. group Id
        OG005
        spread
        0.13
        value
        0.42
      7. group Id
        OG006
        spread
        0.14
        value
        0.40
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    units
    Participants
description
Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours).
dispersion Type
Standard Deviation
groups
  1. description
    This arm of the study will include Dose Defining 100mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG000
    title
    Dose Defining 100mg
  2. description
    This arm of the study will include Dose Defining 200mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG001
    title
    Dose Defining 200mg
  3. description
    This arm of the study will include Dose Defining 400mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG002
    title
    Dose Defining 400mg
  4. description
    This arm of the study will include Dose Defining 500mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG003
    title
    Dose Defining 500mg
  5. description
    This arm of the study will include Dose Defining 600mg cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG004
    title
    Dose Defining 600mg
  6. description
    This arm of the study will include Dose timing of ALM-488 administration 1-3hrs before surgery cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG005
    title
    Dose Timing 1-3hrs
  7. description
    This arm of the study will include Dose timing of ALM-488 administration 3-5hrs before surgery cohort. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG006
    title
    Dose Timing 3-5 Hours.
param Type
MEAN
population Description
Patients were accrued into the Dose Defining Cohorts (Dose Escalation/De-Escalation) and the Dose Timing Cohorts using inclusion and exclusion criteria as specified in the protocol.
reporting Status
POSTED
time Frame
28 (+5) days
title
Time of Peak ALM-488 Concentration in Plasma (Cmax)
type
OTHER_PRE_SPECIFIED
unit Of Measure
hours

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Preserved source evidence · Not medical advice