Human study PLS-00149

A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers.

Randomized controlled trial · Not reported participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers.primary · Annals of the New York Academy of Sciences · 2010-04-01 · PMID 20536472 · DOI

Design and participants

Design: Randomized controlled trial
Population: Healthy volunteers enrolled in four ascending-dose cohorts of 10 subjects each. The split between placebo and active treatment within cohorts is not stated.
Conditions: Healthy volunteers (intended future indication: acute myocardial infarction / cardiac ischemia)
Planned enrollment (registry): Not reported
Enrolled: Not reported
Randomized: Not reported
Completed follow-up: Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

Thymosin β4 intravenous (intervention) · thymosin-beta-4 · Synthetic thymosin beta 4 at ascending dose levels across four cohorts · intravenous · Single dose, then after safety review the same regimen daily for 14 days · Not reported assigned
Placebo intravenous (comparator) · Placebo · placebo · intravenous · Single dose, then daily for 14 days · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Treatment-emergent adverse events

unclear outcome · safety · After a single dose and over 14 days of daily dosing · Incidence and intensity of treatment-emergent adverse events and safety evaluations

Thymosin β4 intravenous: narrative — Adverse events were infrequent and mild or moderate in intensity; not reported separately by arm

Dose-limiting toxicities and serious adverse events

unclear outcome · safety · Single-dose and 14-day multiple-dose phases · Occurrence of dose-limiting toxicity and serious adverse events

Thymosin β4 intravenous: narrative — No dose-limiting toxicities or serious adverse events occurred in the study

Pharmacokinetic parameters

unclear outcome · surrogate · After single dose · Pharmacokinetic profile including dose proportionality and half-life

Thymosin β4 intravenous: narrative — Single-dose pharmacokinetics were dose proportional, with half-life increasing as dose increased

Adverse events

Serious adverse events (serious): 0 participants
Treatment-emergent adverse events (mild or moderate): Not reported participants

Monitoring: Safety evaluations, incidence of treatment-emergent adverse events and pharmacokinetics were assessed. A safety review was done after the single-dose phase before the multiple-dose phase.

The authors concluded (paraphrased): Intravenous synthetic Tβ4, given as a single dose or daily for 14 days across the tested dose range, was well tolerated without dose-limiting toxicity. The authors suggest further development for cardiac ischemia.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

abstract only: Only the abstract is available, so randomization, blinding and arm-level results cannot be verified.
inappropriate population: Participants were healthy volunteers, not patients with the target conditions such as myocardial infarction or other indications.
small or imprecise: Small phase I cohorts of 10 subjects each, split between placebo and active, give limited power to detect uncommon adverse events.
short follow up: Dosing lasted at most 14 days, and no longer-term follow-up for delayed adverse effects is described.
selective reporting: Adverse events are described only narratively and are not broken down by arm or dose, so placebo and active cannot be compared.
funding or conflicts: Funding source and author conflicts of interest are not stated in the available record.
inappropriate endpoint: Safety and pharmacokinetic endpoints only; no clinical efficacy outcomes were assessed.

Treatment-emergent adverse events: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Abstract states placebo-controlled randomization but gives no sequence generation or concealment details.
Deviations from intended interventions	Some concerns	Blinding of participants and staff is not described in the abstract, and deviations are not reported.
Missing outcome data	Some concerns	Numbers completing each phase and any dropouts are not reported in the abstract.
Measurement of the outcome	Some concerns	Adverse event ascertainment may be influenced by knowledge of assignment, and blinding is unreported.
Selection of the reported result	Some concerns	AEs are summarized only narratively, without arm-level data or a prespecified analysis plan available.

Every domain has some concerns because only the abstract is available and key trial conduct details are missing.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Dose-limiting toxicities and serious adverse events: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is stated but the methods for sequence generation and concealment are not reported.
Deviations from intended interventions	Some concerns	No information in the abstract on blinding or protocol deviations during the dosing phases.
Missing outcome data	Some concerns	Completion and withdrawal counts are not given, so missing outcome data cannot be assessed.
Measurement of the outcome	Some concerns	Serious events are fairly objective, but the method of DLT assessment is not described in the abstract.
Selection of the reported result	Some concerns	Only a summary statement of no DLTs or SAEs is reported; the protocol definitions are unavailable.

Abstract-only reporting leaves some concerns in all domains for this outcome.

Pharmacokinetic parameters: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization methods are not described, although PK concerns only the active-treatment subjects.
Deviations from intended interventions	Some concerns	Adherence to the sampling schedule and protocol deviations are not reported in the abstract.
Missing outcome data	Some concerns	Number of subjects contributing PK samples is not stated in the abstract.
Measurement of the outcome	Some concerns	The bioanalytical assay and PK methods are not described in the available abstract text.
Selection of the reported result	Some concerns	PK is described only qualitatively, with no parameter values or analysis plan available.

Lack of methodological detail in the abstract leaves some concerns across all domains.

Claims this study informs

Improves dry eye signs and symptoms: not eligible (wrong population) for “Ocular discomfort and corneal staining”
Is safe for human administration: eligible for “Adverse events, serious adverse events and discontinuations”, direct evidence

Insufficient information to assess Adverse events, serious adverse events and discontinuations

Where each value comes from

adverse_events: PMID 20536472, abstract (sentences 6-7) · extracted by AI (automated, not verified by a person) · abstract only
arms: PMID 20536472, abstract (sentences 2-4) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 20536472, abstract (sentences 9-10) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 20536472, title (title) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 20536472, abstract (sentences 2-6) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 20536472, abstract (sentence 5) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 20536472, abstract (sentence 2) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 20536472, abstract (sentence 2) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 20536472, abstract (sentences 6-8) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).