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, and occurred in 57% of single-dose and 67% of multiple-dose drug recipients against 70% and 83% on placebo; 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 aged 18 to 50 (54 single-dose: 44 drug, 10 placebo; 30 multiple-dose: 24 drug, 6 placebo)

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. Sponsored by Beijing Northland Biotech, whose product was tested, with three sponsor employees among the authors.