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Study · Randomized controlled trial · n = 60 · 2025

8 results

Evaluation of Rusfertide, a Hepcidin Mimetic, on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled Crossover Thorough QT Study in Healthy Participants.

Modi NB, Dinh P, Xue H, Darpo B

Clinical therapeutics30 Sept 2025Cited by 1 (Europe PMC)

PMID41033871 (opens in a new tab)DOI10.1016/j.clinthera.2025.09.002 (opens in a new tab)PepBankPUB-41033871
Publisher pagePubMedAsk about this study
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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 trialSafety outcome

    In healthy adults, rusfertide placebo-corrected QTcF changes ranged from -2.0 to 1.8 ms and closely followed placebo.

    In plain wordsIn healthy adults, rusfertide heart repolarization changes closely followed placebo.

    Peptide
    Rusfertide
    Outcome
    No significant changePlacebo-corrected QTcF change
    Study

    n = 60

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Measurements

    Placebo-corrected ΔQTcF (ΔΔQTcF) LS mean
    −2 to 1.8 ms
    rusfertide 90 mg versus placebo

    Source sentences

    Summary
    The least squares (LS) mean ΔQTcF on rusfertide closely followed the placebo pattern, and LS mean placebo-corrected ΔQTcF (ΔΔQTcF) varied from -2.0 to 1.8 ms.
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adults, rusfertide reached its median plasma concentration peak at 4 hours.

    In plain wordsIn healthy adults, rusfertide reached its median blood concentration peak at 4 hours.

    Peptide
    Rusfertide
    Outcome
    Not applicableTime to peak concentration
    Study

    n = 60

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

    Measurements

    Median time to peak concentration
    4 hours
    rusfertide 90 mg

    Source sentences

    Summary
    Mean rusfertide plasma concentrations increased rapidly, with median peak of 4 hours.
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy adults, geometric mean rusfertide peak concentration was 1100 ng/mL.

    In plain wordsIn healthy adults, average peak rusfertide concentration was 1100 ng/mL.

    Peptide
    Rusfertide
    Outcome
    Not applicablePeak plasma concentration
    Study

    n = 60

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

    Measurements

    Cmax (geometric mean)
    1100 ng/mL
    rusfertide 90 mg

    Source sentences

    Summary
    The geometric mean rusfertide peak concentration (Cmax) was 1100 ng/mL.
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy adults, rusfertide had no clinically relevant effect on heart rate.

    In plain wordsIn healthy adults, rusfertide had no clinically relevant effect on heart rate.

    Peptide
    Rusfertide
    Outcome
    No significant changeHeart rate
    Study

    n = 60

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide did not have a clinically relevant effect on heart rate (HR) or cardiac conduction (PR and QRS interval).
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy adults, rusfertide had no clinically relevant effect on the PR interval.

    In plain wordsIn healthy adults, rusfertide had no clinically relevant effect on the PR heart conduction interval.

    Peptide
    Rusfertide
    Outcome
    No significant changePR interval
    Study

    n = 60

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide did not have a clinically relevant effect on heart rate (HR) or cardiac conduction (PR and QRS interval).
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  6. 06HumanRandomized controlled trialSafety outcome

    In healthy adults, rusfertide had no clinically relevant effect on the QRS interval.

    In plain wordsIn healthy adults, rusfertide had no clinically relevant effect on the QRS heart conduction interval.

    Peptide
    Rusfertide
    Outcome
    No significant changeQRS interval
    Study

    n = 60

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide did not have a clinically relevant effect on heart rate (HR) or cardiac conduction (PR and QRS interval).
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  7. 07HumanRandomized controlled trialMechanism

    In healthy adults, the rusfertide concentration-QTc slope was not statistically significant.

    In plain wordsIn healthy adults, rusfertide blood concentration had no statistically significant relationship with the heart repolarization interval.

    Peptide
    Rusfertide
    Outcome
    No significant changeConcentration-QTc relationship
    Study

    n = 60

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Measurements

    Concentration-QTc slope
    0.00042 ms per ng/mL
    rusfertide population estimate
    Concentration-QTc slope 90% CI
    −0.001172 to 0.002013 ms per ng/mL
    rusfertide population estimate

    Source sentences

    Summary
    Estimated population slope of the rusfertide concentration-QTc relationship was not statistically significant: 0.00042 ms per ng/mL (90% confidence interval [CI]: -0.001172 to 0.002013; P = 0.6624).
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.
  8. 08HumanRandomized controlled trialSafety outcome

    In healthy adults, predicted placebo-corrected QTcF change at geometric mean peak rusfertide concentration was 0.04 ms.

    In plain wordsIn healthy adults, predicted heart repolarization change at peak rusfertide concentration was 0.04 ms after placebo correction.

    Peptide
    Rusfertide
    Outcome
    Not applicablePredicted QTcF change at peak concentration
    Study

    n = 60

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    90 mg · subcutaneousAs given in this study (human).

    Measurements

    Predicted ΔΔQTcF at geometric mean Cmax
    0.04 ms
    rusfertide
    Predicted ΔΔQTcF 90% CI
    −1.21 to 1.29 ms
    rusfertide

    Source sentences

    Summary
    Predicted ΔΔQTcF at the geometric mean Cmax was 0.04 ms (90% CI: -1.21 to 1.29).
    2 context sentences
    Summary · context
    A positive-controlled, randomized, double-blind, crossover study was conducted in healthy adults.
    Summary · context
    Subjects received subcutaneous rusfertide 90 mg, matching subcutaneous placebo, and oral moxifloxacin.

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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