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Study · Randomized controlled trial · n = 30 · 2021

8 results

A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers.

Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, Liu C, Bai H, Han C, Sun Y, Liu J

Journal of cellular and molecular medicine4 Aug 2021Cited by 12 (Europe PMC)

PMID34346165 (opens in a new tab)PMCIDPMC8419156 (opens in a new tab)DOI10.1111/jcmm.16693 (opens in a new tab)PepBankPUB-34346165
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Summary

The study evaluated the safety, tolerability, pharmacokinetics (PK) and anti-drug antibody (ADA) of the recombinant human thymosin β4 (NL005) for single and multiple intravenous injections in healthy subjects. Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days. The cohorts received ascending doses of either 0.05, 0.25, 0.5, 2.0, 5.0, 12.5 or 25.0 μg/kg in the single-dose trial. A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days. The adverse events were mild to moderate in intensity. There were no dose-limiting toxicities or serious adverse events. The plasma concentration, maximum peak concentration (Cmax ) and AUC of each dose group increased with the increase in the dose. The tendency of terminal clearance in each dose group was consistent, and there was no obvious accumulation after continuous administration. Thus, the drug can be concluded to be well tolerated and safe in healthy people and suitable for use in a clinical study for the treatment of acute myocardial infarction.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

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

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, there was no obvious accumulation of rhTβ4 after continuous administration.

    In plain wordsIn healthy people, recombinant thymosin β4 did not clearly build up in the body after repeated doses.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeAccumulation after continuous administration
    Study

    n = 30

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5, 2.0 and 5.0 μg/kg daily · intravenous · 10 daysAs given in this study (human).

    Source sentences

    Summary
    there was no obvious accumulation after continuous administration.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy volunteers, adverse events after rhTβ4 (NL005) were mild to moderate in intensity.

    In plain wordsIn healthy people, side effects after recombinant thymosin β4 were mild to moderate.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05-25.0 μg/kg single dose; 0.5-5.0 μg/kg daily · intravenous · single dose or 10 daysAs given in this study (human).

    Source sentences

    Summary
    The adverse events were mild to moderate in intensity.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy volunteers, there were no dose-limiting toxicities with rhTβ4.

    In plain wordsIn healthy people, recombinant thymosin β4 caused no dose-limiting toxicities.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeDose-limiting toxicities
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05-25.0 μg/kg single dose; 0.5-5.0 μg/kg daily · intravenous · single dose or 10 daysAs given in this study (human).

    Source sentences

    Summary
    There were no dose-limiting toxicities
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy volunteers, there were no serious adverse events with rhTβ4.

    In plain wordsIn healthy people, recombinant thymosin β4 caused no serious side effects.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05-25.0 μg/kg single dose; 0.5-5.0 μg/kg daily · intravenous · single dose or 10 daysAs given in this study (human).

    Source sentences

    Summary
    There were no dose-limiting toxicities or serious adverse events.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, plasma concentration of rhTβ4 increased with the dose.

    In plain wordsIn healthy people, blood levels of recombinant thymosin β4 rose as the dose went up.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    IncreasePlasma concentration by dose
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.05-25.0 μg/kg single dose · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    The plasma concentration, maximum peak concentration (Cmax ) and AUC of each dose group increased with the increase in the dose.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, maximum peak concentration (Cmax) of rhTβ4 increased with the dose.

    In plain wordsIn healthy people, peak blood level of recombinant thymosin β4 rose as the dose went up.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    IncreaseCmax by dose
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.05-25.0 μg/kg single dose · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    The plasma concentration, maximum peak concentration (Cmax ) and AUC of each dose group increased with the increase in the dose.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  7. 07HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, AUC of rhTβ4 increased with the dose.

    In plain wordsIn healthy people, total exposure to recombinant thymosin β4 rose as the dose went up.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    IncreaseAUC by dose
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.05-25.0 μg/kg single dose · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    The plasma concentration, maximum peak concentration (Cmax ) and AUC of each dose group increased with the increase in the dose.
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.
  8. 08HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, the tendency of terminal clearance of rhTβ4 was consistent in each dose group.

    In plain wordsIn healthy people, recombinant thymosin β4 cleared from the body in a similar way at each dose.

    Peptide
    Thymosin beta-4 (human)
    Outcome
    No significant changeTerminal clearance across doses
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.05-25.0 μg/kg single dose; 0.5-5.0 μg/kg daily · intravenous · single dose or 10 daysAs given in this study (human).

    Source sentences

    Summary
    The tendency of terminal clearance in each dose group was consistent
    2 context sentences
    Summary · context
    Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days.
    Summary · context
    A total of 30 healthy subjects were randomly enrolled in the multiple-dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days.

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

    13 Oct 2026, 01:52 UTC

    Study results updated

  2. Version 1

    12 Oct 2026, 18:17 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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