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 Medicine

Adverse events were mild to moderate with no dose-limiting toxicity and no serious adverse events; exposure rose with dose and did not accumulate over ten daily doses. This is the controlled human safety and pharmacokinetic dataset for the full-length protein.

Population

Healthy adult volunteers (54 single-dose, 30 multiple-dose)

Intervention

Intravenous recombinant human Tβ4 (NL005) 0.05–25.0 µg/kg single dose; 0.5, 2.0 or 5.0 µg/kg daily for 10 days

Comparator

Placebo

Limitations

Healthy volunteers, 28-day observation, intravenous full-length protein at microgram-per-kilogram doses — it says nothing about months of milligram-scale subcutaneous fragment injection.