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, et al. J Cell Mol Med. 2021;25(17):8222-8228. PMID: 34346165. DOI: 10.1111/jcmm.16693.
Identity: Related, not interchangeable: recombinant full-length human thymosin β4 (NL005), not the TB-500 fragment
Design & population: Randomised, double-blind phase-I programme in healthy adults. The published report describes single- and multiple-dose components with 54 and 30 participants respectively.
Question studied: Short-term tolerability, pharmacokinetics, and anti-drug antibodies for recombinant full-length thymosin β4.
Record finding: The authors report mild-to-moderate adverse events and no dose-limiting toxicities or serious adverse events during the study observation period.
Does not show: It is not evidence for TB-500, because the molecular identity differs. It also does not test tendon repair, athletic recovery, or long-term safety.