Human study PLS-00173

A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese 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 first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers.primary · Journal of cellular and molecular medicine · 2021-08-04 · PMID 34346165 · DOI

Design and participants

Design: Randomized controlled trial
Population: Healthy Chinese adult volunteers. The single-dose trial had seven ascending-dose cohorts with 54 subjects in total. The multiple-dose trial had three cohorts with 30 subjects in total.
Conditions: Healthy volunteers (intended future indication: acute myocardial infarction)
Setting: Phase I clinical study; site not stated (China)
Planned enrollment (registry): Not reported
Enrolled: Not reported
Randomized: Not reported
Completed follow-up: Not reported
Funding: Indexed as Research Support, Non-U.S. Gov't; funder not named in the record
Authors’ conflicts: Not reported in the record

Intervention and comparator

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

Single-dose NL005 (intervention) · thymosin-beta-4 · Recombinant human thymosin beta-4 (NL005) given as a single intravenous injection in ascending-dose cohorts · intravenous · Single dose, observed for 28 days · Not reported assigned
Single-dose placebo (comparator) · Placebo given as a single intravenous injection within the single-dose cohorts · placebo · intravenous · Single dose, observed for 28 days · Not reported assigned
Multiple-dose NL005 (intervention) · thymosin-beta-4 · Recombinant human thymosin beta-4 given once daily intravenously in three dose cohorts; use of placebo in this part is not stated in the abstract · intravenous · Once daily for 10 days, observed for 28 days · Not reported assigned

What the authors reported

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

Adverse events / tolerability

primary outcome · safety · Through 28 days of observation · Adverse events and their intensity

Single-dose NL005: narrative — Adverse events were mild to moderate in intensity (arms not distinguished)
Multiple-dose NL005: narrative — Adverse events were mild to moderate in intensity (arms not distinguished)

Dose-limiting toxicities and serious adverse events

primary outcome · safety · Through 28 days of observation · Occurrence of dose-limiting toxicities and serious adverse events

Single-dose NL005: narrative — No dose-limiting toxicities or serious adverse events occurred
Multiple-dose NL005: narrative — No dose-limiting toxicities or serious adverse events occurred

Pharmacokinetics (plasma concentration, Cmax, AUC, terminal clearance, accumulation)

secondary outcome · surrogate · After single and multiple dosing · Plasma pharmacokinetic parameters

Single-dose NL005: narrative — Plasma concentration, Cmax and AUC increased with increasing dose; terminal clearance trend was consistent across dose groups
Multiple-dose NL005: narrative — No obvious accumulation after continuous administration

Anti-drug antibodies

secondary outcome · surrogate · Not stated · Anti-drug antibody formation

No results reported.

Adverse events

Adverse events (mild to moderate intensity) · Single-dose NL005: Not reported participants
Adverse events (mild to moderate intensity) · Multiple-dose NL005: Not reported participants
Serious adverse events (serious) · Single-dose NL005: 0 participants
Serious adverse events (serious) · Multiple-dose NL005: 0 participants

Monitoring: Subjects were observed for 28 days after dosing, with assessment of adverse events, dose-limiting toxicities, pharmacokinetics and anti-drug antibodies.

The authors concluded (paraphrased): Recombinant thymosin beta-4 was well tolerated and safe in healthy volunteers. Its exposure rose with dose and it showed no obvious accumulation. The authors judged it suitable for clinical study in acute myocardial infarction.

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 methods, per-arm counts and adverse event details cannot be verified.
inappropriate population: Healthy volunteers were studied, not patients with the target disease, which limits applicability to patients.
small or imprecise: Small phase I cohorts split across many dose levels give little power to detect uncommon adverse events.
short follow up: Observation lasted only 28 days, which is too short to capture delayed or long-term harms.
selective reporting: The abstract gives no adverse event counts by arm, and anti-drug antibody results are not reported despite being an objective.

Adverse events / tolerability: 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	Described as randomized, but sequence generation and allocation concealment are not reported in the abstract.
Deviations from intended interventions	Some concerns	Described as double-blind, but adherence and deviations are not described in the abstract.
Missing outcome data	Some concerns	The number of completers and any dropouts are not reported in the abstract.
Measurement of the outcome	Some concerns	Blinding may protect adverse event assessment, but the methods of AE ascertainment are not described.
Selection of the reported result	Some concerns	Adverse events are summarized only narratively, without per-arm counts or a prespecified plan visible.

The trial is randomized and double-blind, but the abstract-only record lacks details across all domains.

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.

Pharmacokinetics (plasma concentration, Cmax, AUC, terminal clearance, accumulation): 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 its methods are not reported; PK comparisons are across dose cohorts.
Deviations from intended interventions	Some concerns	Dosing adherence and protocol deviations are not described in the abstract.
Missing outcome data	Some concerns	The number of subjects with evaluable PK samples is not reported in the abstract.
Measurement of the outcome	Some concerns	Plasma assays are objective, but the bioanalytical method is not described in the abstract.
Selection of the reported result	Some concerns	PK results are given only narratively, without numerical parameters in the abstract.

An objective laboratory outcome, but the abstract-only reporting leaves the methods and data unverifiable.

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 34346165, abstract (sentences 5-6) · extracted by AI (automated, not verified by a person) · abstract only
arms: PMID 34346165, abstract (sentences 2-4) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 34346165, abstract (sentence 9) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 34346165, title (title) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 34346165, abstract (sentences 2-6) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 34346165, abstract (sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 34346165, abstract (sentences 2 and 4) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 34346165, abstract (sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 34346165, abstract (sentences 5-8) · 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).