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Study · Randomized controlled trial · 2024

8 results

Pharmacokinetics, pharmacodynamics, and tolerability of an aqueous formulation of rusfertide (PTG-300), a hepcidin mimetic, in healthy volunteers: A double-blind first-in-human study.

Modi NB, Shames R, Lickliter JD, Gupta S

European journal of haematology24 May 2024Cited by 8 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, rusfertide peak plasma concentration increased less than proportionally with dose.

    In plain wordsIn healthy adult men, rusfertide peak blood concentration increased less than proportionally with dose.

    Peptide
    Rusfertide
    Outcome
    IncreaseDose dependence of peak concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Mean maximum rusfertide plasma concentration (Cmax) and area under the concentration-time curve increased with dose, but less than dose proportionally.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, rusfertide area under the concentration-time curve increased less than proportionally with dose.

    In plain wordsIn healthy adult men, total rusfertide exposure increased less than proportionally with dose.

    Peptide
    Rusfertide
    Outcome
    IncreaseDose dependence of exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Mean maximum rusfertide plasma concentration (Cmax) and area under the concentration-time curve increased with dose, but less than dose proportionally.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, median rusfertide time to peak concentration was 2-4.5 h at 40 and 80 mg.

    In plain wordsIn healthy adult men, rusfertide blood concentration peaked after 2-4.5 h at 40 and 80 mg.

    Peptide
    Rusfertide
    Outcome
    Not applicableTime to peak concentration at higher doses
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 and 80 mg · subcutaneousAs given in this study (human).

    Measurements

    Median time to Cmax
    2 to 4.5 h
    40 and 80 mg rusfertide

    Source sentences

    Summary
    Median time to Cmax was 2-4.5 h for 40 and 80 mg rusfertide and 8-24 h for lower doses.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, median rusfertide time to peak concentration was 8-24 h at lower doses.

    In plain wordsIn healthy adult men, rusfertide blood concentration peaked after 8-24 h at lower doses.

    Peptide
    Rusfertide
    Outcome
    Not applicableTime to peak concentration at lower doses
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1, 3, 10, or 20 mg · subcutaneousAs given in this study (human).

    Measurements

    Median time to Cmax
    8 to 24 h
    lower doses (1, 3, 10, 20 mg)

    Source sentences

    Summary
    Median time to Cmax was 2-4.5 h for 40 and 80 mg rusfertide and 8-24 h for lower doses.
    2 context sentences
    Summary · context
    Subjects received single doses of 1, 3, 10, 20, 40, or 80 mg rusfertide or placebo.
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, rusfertide apparent clearance increased with dose.

    In plain wordsIn healthy adult men, apparent rusfertide clearance increased with dose.

    Peptide
    Rusfertide
    Outcome
    IncreaseApparent clearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Apparent clearance and half-life increased with dose.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy adult males, rusfertide half-life increased with dose.

    In plain wordsIn healthy adult men, rusfertide remained in the body longer at higher doses.

    Peptide
    Rusfertide
    Outcome
    IncreaseHalf-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Apparent clearance and half-life increased with dose.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In healthy adult males, single rusfertide doses produced dose-dependent decreases in serum iron.

    In plain wordsIn healthy adult men, single rusfertide doses lowered blood iron in a dose-dependent manner.

    Peptide
    Rusfertide
    Outcome
    DecreaseSerum iron
    Study

    n: not reported in source

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    1-80 mg single dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Single doses of rusfertide 1-80 mg were associated with dose-dependent decreases in serum iron and transferrin-iron saturation.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In healthy adult males, single rusfertide doses produced dose-dependent decreases in transferrin-iron saturation.

    In plain wordsIn healthy adult men, single rusfertide doses lowered transferrin iron saturation in a dose-dependent manner.

    Peptide
    Rusfertide
    Outcome
    DecreaseTransferrin-iron saturation
    Study

    n: not reported in source

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    1-80 mg single dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Single doses of rusfertide 1-80 mg were associated with dose-dependent decreases in serum iron and transferrin-iron saturation.
    1 context sentence
    Summary · context
    This randomized, placebo-controlled, double-blind study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and repeated subcutaneous doses of an aqueous formulation of rusfertide in healthy adult males.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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