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Study · Randomized controlled trial · n = 9 · 1999

11 results

Pharmacokinetics of thymosin alpha1 after subcutaneous injection of three different formulations in healthy volunteers.

Rost KL, Wierich W, Masayuki F, Tuthill CW, Horwitz DL, Herrmann WM

International journal of clinical pharmacology and therapeutics1 Jan 1999Cited by 11 (Europe PMC)

PMID10027483 (opens in a new tab)PepBankPUB-10027483

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    After subcutaneous injection in healthy volunteers, thymosin alpha1 was well absorbed with a mean tmax of 1-2 hours from all formulations.

    In plain wordsIn healthy volunteers, thymosin alpha1 injected under the skin was well absorbed and peaked in blood after 1 to 2 hours.

    Outcome
    Not applicableTime to maximum concentration (tmax)
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Measurements

    tmax
    1 to 2 h
    all formulations

    Source sentences

    Summary
    Thymosin alpha1 was well absorbed with a mean t(max) between 1-2 hours from all galenic formulations.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  2. 02HumanRandomized controlled trialPharmacokinetics

    After subcutaneous injection in healthy volunteers, Cmax of thymosin alpha1 ranged from 30 to 80 µg/l across drugs.

    In plain wordsIn healthy volunteers, peak thymosin alpha1 levels in blood were 30 to 80 µg/l across the formulations.

    Outcome
    Not applicableCmax
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Measurements

    Cmax
    30 to 80 µg/l
    all drugs

    Source sentences

    Summary
    Cmax concentrations of 30 to 80 microg/l and AUC(0-infinity) from 95 to 267 microg x h/l did not differ between single- and multiple-dose administration of all drugs.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  3. 03HumanRandomized controlled trialPharmacokinetics

    After subcutaneous injection in healthy volunteers, AUC(0-infinity) of thymosin alpha1 ranged from 95 to 267 µg x h/l across drugs.

    In plain wordsIn healthy volunteers, total thymosin alpha1 exposure in blood was 95 to 267 µg x h/l across the formulations.

    Outcome
    Not applicableAUC(0-infinity)
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Measurements

    AUC(0-infinity)
    95 to 267 µg x h/l
    all drugs

    Source sentences

    Summary
    Cmax concentrations of 30 to 80 microg/l and AUC(0-infinity) from 95 to 267 microg x h/l did not differ between single- and multiple-dose administration of all drugs.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, Cmax and AUC of thymosin alpha1 did not differ between single and multiple dosing, which indicates no accumulation.

    In plain wordsIn healthy volunteers, thymosin alpha1 did not build up in the body after 5 days of dosing compared with a single dose.

    Outcome
    No significant changeAccumulation, single versus multiple dose
    Study

    n = 9

    Comparator
    Single dose
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Source sentences

    Summary
    Cmax concentrations of 30 to 80 microg/l and AUC(0-infinity) from 95 to 267 microg x h/l did not differ between single- and multiple-dose administration of all drugs. This apparent lack of accumulation was supported by the short elimination half-life of less than 3 hours.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, the elimination half-life of thymosin alpha1 was less than 3 hours.

    In plain wordsIn healthy volunteers, thymosin alpha1 cleared from the body quickly, with a half-life under 3 hours.

    Outcome
    Not applicableElimination half-life
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Measurements

    Elimination half-life
    < 3 h
    all formulations

    Source sentences

    Summary
    This apparent lack of accumulation was supported by the short elimination half-life of less than 3 hours.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, Vz/f of thymosin alpha1 was 30-40 l, which suggests distribution within the extracellular volume.

    In plain wordsIn healthy volunteers, thymosin alpha1 appears to spread within the fluid outside cells.

    Outcome
    Not applicableVolume of distribution (Vz/f)
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Measurements

    Vz/f
    30 to 40 l
    all formulations

    Source sentences

    Summary
    As indicated by a V(Z)/f in the range of 30-40 l, thymosin alpha1 appears to distribute within the extracellular volume.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  7. 07HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, AUC of thymosin alpha1 was similar for Zadaxin and Tal-HLR.

    In plain wordsIn healthy volunteers, total exposure to thymosin alpha1 was similar for Zadaxin and the Roche formulation.

    Outcome
    No significant changeAUC, Zadaxin versus Tal-HLR
    Study

    n = 9

    Comparator
    Thymosin alpha1 (Tal-HLR)
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Source sentences

    Summary
    AUC and Cmax were similar for Zadaxin and T alpha1-HLR
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  8. 08HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, Cmax of thymosin alpha1 was similar for Zadaxin and Tal-HLR.

    In plain wordsIn healthy volunteers, peak levels of thymosin alpha1 were similar for Zadaxin and the Roche formulation.

    Outcome
    No significant changeCmax, Zadaxin versus Tal-HLR
    Study

    n = 9

    Comparator
    Thymosin alpha1 (Tal-HLR)
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Source sentences

    Summary
    AUC and Cmax were similar for Zadaxin and T alpha1-HLR
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  9. 09HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, AUC of thymosin alpha1 was higher after Timosina than after Zadaxin and Tal-HLR.

    In plain wordsIn healthy volunteers, total exposure to thymosin alpha1 was higher with Timosina than with the other two formulations.

    Outcome
    IncreaseAUC, Timosina versus other formulations
    Study

    n = 9

    Comparator
    Zadaxin and Tal-HLR
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Source sentences

    Summary
    AUC and Cmax were similar for Zadaxin and T alpha1-HLR, but higher after administration of Timosina.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…
  10. 10HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, Cmax of thymosin alpha1 was higher after Timosina than after Zadaxin and Tal-HLR.

    In plain wordsIn healthy volunteers, peak levels of thymosin alpha1 were higher with Timosina than with the other two formulations.

    Outcome
    IncreaseCmax, Timosina versus other formulations
    Study

    n = 9

    Comparator
    Zadaxin and Tal-HLR
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    900 µg/m2 · subcutaneous · single dose and 5 daysAs given in this study (human).

    Source sentences

    Summary
    AUC and Cmax were similar for Zadaxin and T alpha1-HLR, but higher after administration of Timosina.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…

Natural levels measured1

These results measure the body's own peptide. Nobody was given the peptide. They are not evidence about taking it. They are left out of key results, evidence counts and charts.

  1. 11HumanEndogenous levelRandomized controlled trialPharmacokinetics

    In healthy volunteers, the body's own serum thymosin alpha1 was below the 0.10 µg/l limit of quantification in most subjects.

    In plain wordsIn healthy volunteers, the body's own thymosin alpha1 in blood was too low to measure in most people.

    Outcome
    Not applicableEndogenous serum thymosin alpha1
    Study

    n = 9

    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Limit of quantification
    0.1 µg/l
    ELISA

    Source sentences

    Summary
    Endogenous serum concentrations were below the limit of quantification (0.10 microg/l) of the enzyme-linked immunosorbent assay method in most subjects.
    1 context sentence
    Summary · context
    In this study, single- and 5-day multiple-dose pharmacokinetics were characterized in nine Caucasian volunteers after subcutaneous administration of 900 microg/m2 thymosin alpha1.MethodsUsing a randomized, 3-way crossover design three available drug formulations were compared: Zadaxin (SciC…

    This result measures the body's own Thymosin alpha-1. Nobody was given the peptide. It is not evidence about taking it.

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 3Current

    10 Oct 2026, 08:55 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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