Synthetic thymosin beta 4 phase 1
A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers.
Ruff D, Crockford D, Girardi G, Zhang Y. · Annals of the New York Academy of Sciences
Study record
- Population
Four cohorts of 10 healthy volunteers each; treatment allocation counts not specified in the abstract.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Formulation
Synthetic thymosin beta 4 or placebo; detailed formulation not verified.
Inspect extraction gap · Abstract-level extractionPrimary abstract — study methods and findings- Route
Intravenous.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Dose & frequency
Cohorts received 42, 140, 420 or 1,260 mg, followed after safety review by daily administration for 14 days. Reported units are mg, not NL005’s μg/kg. No human or KLOW regimen is inferred.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Study design
Randomized placebo-controlled single- and multiple-dose phase 1 assessment.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Duration
Single-dose exposure followed by a 14-day repeated-dose period; subsequent follow-up not specified.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Reported findings
Examined pharmacokinetics and tolerability, not efficacy for myocardial infarction.
Read source · Abstract-level extractionPrimary abstract — study methods and findings- Adverse events
Abstract reports infrequent mild/moderate events and no serious events or dose-limiting toxicity; event counts unavailable.
Inspect extraction gap · Abstract-level extractionPrimary abstract — study methods and findings- Monitoring
Detailed safety-monitoring schedule unavailable in the abstract.
Inspect extraction gap · Abstract-level extractionPrimary abstract — reporting limit
What it supports
Examined pharmacokinetics and tolerability, not efficacy for myocardial infarction.
What it does not establish
Small healthy-volunteer cohorts; no clinical efficacy or long-term safety conclusion. Different product and units from recombinant NL005; do not combine dosing data. Abstract-level extraction; source gaps are not evidence of safety.
Funding
Not stated in retrieved abstract.
Literature search cutoff: 2026-09-08 · Not independently clinically reviewed
Browse study library