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Study · Randomized controlled trial · n = 18 · 2025

19 results

Multiple-Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Subcutaneous Rusfertide, a Hepcidin Mimetic, in Healthy Subjects.

Modi NB, Dinh P, Ajari I

Clinical pharmacology in drug development29 Jan 2025Cited by 2 (Europe PMC)

PMID39888264 (opens in a new tab)PMCIDPMC11975206 (opens in a new tab)DOI10.1002/cpdd.1514 (opens in a new tab)PepBankPUB-39888264
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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 study19

19 results from studies that gave the peptide. 19 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, first-dose rusfertide peak concentrations differed by injection site: 547, 387, and 560 ng/mL in abdomen, thigh, and arm.

    In plain wordsIn healthy subjects, first-dose peak rusfertide levels differed between abdomen, thigh, and arm injections.

    Peptide
    Rusfertide
    Outcome
    MixedFirst-dose peak plasma concentration by injection site
    Study

    n = 18

    Comparator
    Abdomen, thigh, and arm injection sites
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Measurements

    Cmax
    547 ng/mL
    abdomen
    Cmax
    387 ng/mL
    thigh
    Cmax
    560 ng/mL
    arm

    Source sentences

    Summary
    Geometric mean peak rusfertide plasma concentrations (Cmax) following the first dose were 547, 387, and 560 ng/mL following injection in the abdomen, thigh, and arm, respectively (P = .0054).
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, first-dose rusfertide AUC did not differ between injection sites.

    In plain wordsIn healthy subjects, first-dose rusfertide blood exposure did not differ between injection sites.

    Peptide
    Rusfertide
    Outcome
    No significant changeFirst-dose AUC by injection site
    Study

    n = 18

    Comparator
    Other injection sites
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There was no difference between injection sites in the rusfertide area under the plasma concentration-time curve (AUC) following the first dose (P ≥ .179) or in the Cmax or AUC during the dosing interval following the last dose (P ≥ .238).
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, last-dose rusfertide peak concentration did not differ between injection sites.

    In plain wordsIn healthy subjects, last-dose peak rusfertide levels did not differ between injection sites.

    Peptide
    Rusfertide
    Outcome
    No significant changeLast-dose Cmax by injection site
    Study

    n = 18

    Comparator
    Other injection sites
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There was no difference between injection sites in the rusfertide area under the plasma concentration-time curve (AUC) following the first dose (P ≥ .179) or in the Cmax or AUC during the dosing interval following the last dose (P ≥ .238).
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, last-dose rusfertide AUC did not differ between injection sites.

    In plain wordsIn healthy subjects, last-dose rusfertide blood exposure did not differ between injection sites.

    Peptide
    Rusfertide
    Outcome
    No significant changeLast-dose AUC by injection site
    Study

    n = 18

    Comparator
    Other injection sites
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There was no difference between injection sites in the rusfertide area under the plasma concentration-time curve (AUC) following the first dose (P ≥ .179) or in the Cmax or AUC during the dosing interval following the last dose (P ≥ .238).
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, geometric mean rusfertide AUC accumulation was 1.5 and was similar across injection sites.

    In plain wordsIn healthy subjects, rusfertide blood exposure accumulated 1.5-fold, similarly across injection sites.

    Peptide
    Rusfertide
    Outcome
    IncreaseAUC accumulation
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Measurements

    AUC accumulation ratio
    1.5 ratio
    Dose 5/Dose 1

    Source sentences

    Summary
    Geometric mean accumulation (Dose 5/Dose 1) for AUC and Cmax was 1.5 and 1.2, respectively, and similar across injection sites.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, geometric mean rusfertide peak concentration accumulation was 1.2 and was similar across injection sites.

    In plain wordsIn healthy subjects, peak rusfertide levels accumulated 1.2-fold, similarly across injection sites.

    Peptide
    Rusfertide
    Outcome
    IncreaseCmax accumulation
    Study

    n = 18

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Measurements

    Cmax accumulation ratio
    1.2 ratio
    Dose 5/Dose 1

    Source sentences

    Summary
    Geometric mean accumulation (Dose 5/Dose 1) for AUC and Cmax was 1.5 and 1.2, respectively, and similar across injection sites.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  7. 07HumanRandomized controlled trialMechanism

    In healthy subjects, multiple rusfertide doses decreased serum iron.

    In plain wordsIn healthy subjects, repeated rusfertide doses reduced serum iron.

    Peptide
    Rusfertide
    Outcome
    DecreaseSerum iron
    Study

    n = 18

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Mechanism-based decreases in serum iron, transferrin-iron saturation, hemoglobin, and hematocrit were noted following multiple doses.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  8. 08HumanRandomized controlled trialMechanism

    In healthy subjects, multiple rusfertide doses decreased transferrin-iron saturation.

    In plain wordsIn healthy subjects, repeated rusfertide doses reduced transferrin iron saturation.

    Peptide
    Rusfertide
    Outcome
    DecreaseTransferrin-iron saturation
    Study

    n = 18

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Mechanism-based decreases in serum iron, transferrin-iron saturation, hemoglobin, and hematocrit were noted following multiple doses.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  9. 09HumanRandomized controlled trialMechanism

    In healthy subjects, multiple rusfertide doses decreased hemoglobin.

    In plain wordsIn healthy subjects, repeated rusfertide doses reduced hemoglobin.

    Peptide
    Rusfertide
    Outcome
    DecreaseHemoglobin
    Study

    n = 18

    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Mechanism-based decreases in serum iron, transferrin-iron saturation, hemoglobin, and hematocrit were noted following multiple doses.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  10. 10HumanRandomized controlled trialMechanism

    In healthy subjects, multiple rusfertide doses decreased hematocrit.

    In plain wordsIn healthy subjects, repeated rusfertide doses reduced hematocrit.

    Peptide
    Rusfertide
    Outcome
    DecreaseHematocrit
    Study

    n = 18

    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Mechanism-based decreases in serum iron, transferrin-iron saturation, hemoglobin, and hematocrit were noted following multiple doses.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  11. 11HumanRandomized controlled trialMechanism

    In healthy subjects, rusfertide-induced change in hematocrit did not differ between injection sites.

    In plain wordsIn healthy subjects, hematocrit changes with rusfertide did not differ between injection sites.

    Peptide
    Rusfertide
    Outcome
    No significant changeHematocrit response by injection site
    Study

    n = 18

    Comparator
    Other injection sites
    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no differences between injection sites in the pharmacodynamic effect as measured by change from baseline in hematocrit values.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  12. 12HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, no serious adverse events occurred.

    In plain wordsIn healthy subjects receiving rusfertide, no serious side effects occurred.

    Peptide
    Rusfertide
    Outcome
    Not applicableSerious adverse events
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no serious adverse events.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  13. 13HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, injection-site reactions (erythema, induration, pruritus) were among treatment-emergent adverse events reported in 2 or more subjects.

    In plain wordsIn healthy subjects receiving rusfertide, injection-site reactions such as redness, hardening and itching were among side effects reported in 2 or more subjects.

    Peptide
    Rusfertide
    Outcome
    Not applicableInjection-site reactions
    Study

    n = 18

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment-emergent adverse events in 2 or more subjects were injection-site reactions (erythema, induration, pruritus), fatigue, and headache.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  14. 14HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, fatigue occurred in 2 or more subjects.

    In plain wordsIn healthy subjects receiving rusfertide, 2 or more subjects reported fatigue.

    Peptide
    Rusfertide
    Outcome
    Not applicableFatigue
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment-emergent adverse events in 2 or more subjects were injection-site reactions (erythema, induration, pruritus), fatigue, and headache.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  15. 15HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, headache occurred in 2 or more subjects.

    In plain wordsIn healthy subjects receiving rusfertide, 2 or more subjects reported headache.

    Peptide
    Rusfertide
    Outcome
    Not applicableHeadache
    Study

    n = 18

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment-emergent adverse events in 2 or more subjects were injection-site reactions (erythema, induration, pruritus), fatigue, and headache.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  16. 16HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, safety laboratory parameters showed no clinically relevant findings.

    In plain wordsIn healthy subjects receiving rusfertide, safety laboratory tests showed no clinically relevant findings.

    Peptide
    Rusfertide
    Outcome
    No significant changeSafety laboratory parameters
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no clinically relevant findings in the safety laboratory parameters, vital signs, electrocardiograms, or physical examination.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  17. 17HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, vital signs showed no clinically relevant findings.

    In plain wordsIn healthy subjects receiving rusfertide, vital signs showed no clinically relevant findings.

    Peptide
    Rusfertide
    Outcome
    No significant changeVital signs
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no clinically relevant findings in the safety laboratory parameters, vital signs, electrocardiograms, or physical examination.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  18. 18HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, electrocardiograms showed no clinically relevant findings.

    In plain wordsIn healthy subjects receiving rusfertide, heart electrical tests showed no clinically relevant findings.

    Peptide
    Rusfertide
    Outcome
    No significant changeElectrocardiograms
    Study

    n = 18

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no clinically relevant findings in the safety laboratory parameters, vital signs, electrocardiograms, or physical examination.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.
  19. 19HumanRandomized controlled trialSafety outcome

    In healthy subjects receiving rusfertide, physical examinations showed no clinically relevant findings.

    In plain wordsIn healthy subjects receiving rusfertide, physical examinations showed no clinically relevant findings.

    Peptide
    Rusfertide
    Outcome
    No significant changePhysical examination
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    60 mg once weekly · subcutaneous · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no clinically relevant findings in the safety laboratory parameters, vital signs, electrocardiograms, or physical examination.
    2 context sentences
    Summary · context
    This trial investigated the multiple-dose pharmacokinetics, pharmacodynamics, and safety of once-weekly rusfertide 60 mg for 5 weeks in healthy subjects.
    Summary · context
    Subjects were randomized to subcutaneous injection in the abdomen, upper arm, or thigh.

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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